<clinical_study>
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    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268005</url>
  </required_header>
  <id_info>
    <org_study_id>NN1218-4113</org_study_id>
    <secondary_id>U1111-1180-0636</secondary_id>
    <secondary_id>2016-000878-38</secondary_id>
    <nct_id>NCT03268005</nct_id>
  </id_info>
  <brief_title>Research Study Comparing a New Medicine &quot;Fast-acting Insulin Aspart&quot; to Another Already Available Medicine &quot;NovoRapid&quot;/&quot;NovoLog&quot; in People With Type 2 Diabetes</brief_title>
  <acronym>onset 9</acronym>
  <official_title>Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Type 2 Diabetes (Onset® 9)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new&#xD;
      medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting&#xD;
      insulin aspart will be tested to see how well it works and if it is safe. Participants will&#xD;
      get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is&#xD;
      decided by chance. Both medicines will be taken together with insulin degludec. Participants&#xD;
      will need to take 1 injection 4 times every day (all insulins will be provided in pens). The&#xD;
      study will last for about 8 months (34 weeks).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">January 29, 2019</completion_date>
  <primary_completion_date type="Actual">January 7, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Sponsor staff involved in the clinical trial is masked according to company standard procedures.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Glycosylated Haemoglobin (HbA1c)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 1-hour PPG Increment</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 1,5-anhydroglucitol</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieved HbA1c &lt;7.0% (53 mmol/L) (Yes/No)</measure>
    <time_frame>16 weeks after randomisation</time_frame>
    <description>Number of participants reaching HbA1c &lt;7.0% (53 mmol/L) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieved HbA1c &lt;7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)</measure>
    <time_frame>16 weeks after randomisation</time_frame>
    <description>Number of participants reaching HbA1c &lt;7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-9-7 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. PPG increment based on the 7-9-7-point profiles were derived separately for PG measurements made at 1 hour after main meals (breakfast, lunch and main evening meal). PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-9-7 point SMPG profile from baseline (week 0) after 16 weeks of randomisation (i.e., week 16). The results are presented as ratio to baseline. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieved Overall PPG (1 Hour) &lt;7.8 mmol/L (140 mg/dL) (Yes/No)</measure>
    <time_frame>16 weeks after randomisation</time_frame>
    <description>Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Who Achieved Overall PPG &lt;7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)</measure>
    <time_frame>16 weeks after randomisation</time_frame>
    <description>Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Bolus Insulin Dose: in Units/Day</measure>
    <time_frame>16 weeks from randomisation</time_frame>
    <description>Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Bolus Insulin Dose: in Units/kg/Day</measure>
    <time_frame>16 weeks from randomisation</time_frame>
    <description>Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Basal Insulin Dose: in Units/Day</measure>
    <time_frame>16 weeks from randomisation</time_frame>
    <description>Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Basal Insulin Dose: in Units/kg/Day</measure>
    <time_frame>16 weeks from randomisation</time_frame>
    <description>Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual Meal Insulin Dose: in Units</measure>
    <time_frame>16 weeks from randomisation</time_frame>
    <description>Individual meal time bolus insulin dose (Units) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual Meal Insulin Dose: in Units/kg</measure>
    <time_frame>16 weeks from randomisation</time_frame>
    <description>Individual meal time bolus insulin dose (Units/kg) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values are given as ratio to baseline (week 0) after 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Adverse Events</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>Number of treatment emergent adverse events were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Injection Site Reactions</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>Number of treatment emergent injection site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>ADA classification of hypos:&#xD;
Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.&#xD;
Documented symptomatic: PG ≤3.9 mmol/L with symptoms.&#xD;
Asymptomatic: PG ≤3.9 mmol/L without symptoms.&#xD;
Probable symptomatic: No measurement with symptoms.&#xD;
Pseudo: PG &gt;3.9 mmol/L with symptoms.&#xD;
Unclassifiable.&#xD;
NN classification of hypos:&#xD;
BG confirmed: PG &lt;3.1 mmol/L with/without symptoms.&#xD;
Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG &lt;3.1 mmol/L with symptoms.&#xD;
Severe or BG confirmed: Severe as per ADA and BG confirmed by PG &lt;3.1 mmol/L with/without symptoms.&#xD;
Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal</measure>
    <time_frame>Weeks 0-16</time_frame>
    <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physical Examination</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Participants with physical examination findings, normal, abnormal NCS (non- clinically significant) and abnormal CS (clinically significant) at baseline (week 0) and week 16 presented. Results are based on the data from the on-treatment observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system 2) Central &amp; Peripheral nervous system 3) Gastrointestinal system incl. mouth 4) Head, ears, eyes, nose, throat and neck 5) Musculoskeletal system 6) Respiratory system 7) Skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change in vital signs - systolic and diastolic blood pressure from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Signs: Pulse</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change in vital signs - pulse from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Electrocardiogram (ECG)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in electrocardiogram (ECG) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fundoscopy/Fundus Photography</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in fundoscopy/fundus photography from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology - Haematocrit</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in haematology - haematocrit from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology - Haemoglobin</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in haematology - haemoglobin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology - Leukocytes</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in haematology - leukocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology - Thrombocytes</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in haematology - thrombocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology - Erythrocytes</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in haematology - erythrocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - alanine aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Alkaline Phosphatase</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - alkaline phosphatase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - aspratate aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Albumin</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - albumin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Creatinine</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - creatinine from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Potassium</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - potassium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Sodium</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - sodium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Total Bilirubin</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - total bilirubin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemistry - Total Protein</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in biochemistry - total protein from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Changes in body weight from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Mass Index (BMI)</measure>
    <time_frame>Week 0, week 16</time_frame>
    <description>Change in the body mass index (BMI) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1264</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Faster aspart + insulin degludec with or without metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NovoRapid/NovoLog + insulin degludec with or without metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faster-acting insulin aspart</intervention_name>
    <description>Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.</description>
    <arm_group_label>Faster aspart + insulin degludec with or without metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin aspart</intervention_name>
    <description>Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.</description>
    <arm_group_label>NovoRapid/NovoLog + insulin degludec with or without metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin degludec</intervention_name>
    <description>Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.</description>
    <arm_group_label>Faster aspart + insulin degludec with or without metformin</arm_group_label>
    <arm_group_label>NovoRapid/NovoLog + insulin degludec with or without metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Only participants who took metformin before the study should take metformin tablets, same dose as before the study</description>
    <arm_group_label>Faster aspart + insulin degludec with or without metformin</arm_group_label>
    <arm_group_label>NovoRapid/NovoLog + insulin degludec with or without metformin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing&#xD;
        informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to&#xD;
        screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer&#xD;
        prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal&#xD;
        insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times&#xD;
        daily. Treatment with premixed insulin or soluble insulin combination is not considered a&#xD;
        basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended&#xD;
        release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory&#xD;
        at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction,&#xD;
        stroke, hospitalization for unstable angina or transient ischaemic attack within the past&#xD;
        180 days prior to the day of screening (Visit 1). - Subjects presently classified as being&#xD;
        in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral&#xD;
        artery revascularisation known on the day of screening (Visit 1). - Treatment with&#xD;
        injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). -&#xD;
        Anticipated initiation or change in concomitant medications (for more than 14 consecutive&#xD;
        days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid&#xD;
        hormones, or corticosteroids).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Norco</city>
        <state>California</state>
        <zip>92860</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Valparaiso</city>
        <state>Indiana</state>
        <zip>46383</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052-2649</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nashua</city>
        <state>New Hampshire</state>
        <zip>03063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Northport</city>
        <state>New York</state>
        <zip>11768</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>West Seneca</city>
        <state>New York</state>
        <zip>14224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104-5020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605-4254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78749</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bennington</city>
        <state>Vermont</state>
        <zip>05201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>South Burlington</city>
        <state>Vermont</state>
        <zip>05403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601-3834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Olympia</city>
        <state>Washington</state>
        <zip>98502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Caba</city>
        <zip>C1060ABA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Caba</city>
        <zip>C1440AAD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Córdoba</city>
        <zip>5008</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kozloduy</city>
        <zip>3320</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Razgrad</city>
        <zip>7200</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1618</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8V 4A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4N 7L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Concord</city>
        <state>Ontario</state>
        <zip>L4K 4M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Etobicoke</city>
        <state>Ontario</state>
        <zip>M9R 4E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8M 1K7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 5G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Thunder Bay</city>
        <state>Ontario</state>
        <zip>P7A 4V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4T 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Karlovac</city>
        <zip>47000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osijek</city>
        <zip>31 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Varazdin</city>
        <zip>42 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Plzen</city>
        <zip>30100</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Plzen</city>
        <zip>32600</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Trutnov</city>
        <zip>541 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dresden</city>
        <zip>01219</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Falkensee</city>
        <zip>14612</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lingen</city>
        <zip>49808</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Ingbert-Oberwürzbach</city>
        <zip>66386</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Schweinfurt</city>
        <zip>97421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Athens</city>
        <zip>115 25</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Athens</city>
        <zip>GR-11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ioannina</city>
        <zip>45500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Larissa</city>
        <zip>GR-41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Thessaloniki</city>
        <zip>GR-54636</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Thessaloniki</city>
        <zip>GR-54642</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Thessaloniki</city>
        <zip>GR-54643</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Thessaloniki</city>
        <zip>GR-57001</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cittadella (PD)</city>
        <zip>35013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Milano (MI)</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Olbia</city>
        <zip>07026</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Palermo</city>
        <zip>90129</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bucheon</city>
        <zip>14647</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Daegu</city>
        <zip>42472</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seongnam-si</city>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>04516</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wonju</city>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-435</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Skorzewo</city>
        <zip>60-185</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>00-465</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>02-793</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-381</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Baia Mare</city>
        <state>Maramures</state>
        <zip>430222</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tirgu Mures</city>
        <state>Mures</state>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Timisoara</city>
        <state>Timis</state>
        <zip>300125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Brasov</city>
        <zip>500101</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Brasov</city>
        <zip>500283</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>13682</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kazan</city>
        <zip>420073</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>123448</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Penza</city>
        <zip>440026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194356</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tumen</city>
        <zip>625023</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Voronezh</city>
        <zip>394018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Zajecar</city>
        <zip>19000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kosice</city>
        <zip>040 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kysucke Nove Mesto</city>
        <zip>024 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lubochna</city>
        <zip>03491</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lucenec</city>
        <zip>984 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Zilina</city>
        <zip>01001</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Alcobendas</city>
        <zip>28100</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Almería</city>
        <zip>04001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>La Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dnipro</city>
        <zip>49038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03049</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lviv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ternopil</city>
        <zip>46002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Lane WS, Favaro E, Rathor N, Jang HC, Kjaersgaard MIS, Oviedo A, Rose L, Senior P, Sesti G, Soto Gonzalez A, Franek E. A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9). Diabetes Care. 2020 Aug;43(8):1710-1716. doi: 10.2337/dc19-2232. Epub 2020 Mar 24.</citation>
    <PMID>32209647</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <results_first_submitted>January 7, 2020</results_first_submitted>
  <results_first_submitted_qc>February 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 12, 2020</results_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Insulin Aspart</mesh_term>
    <mesh_term>Insulin, Long-Acting</mesh_term>
    <mesh_term>Insulin degludec, insulin aspart drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03268005/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03268005/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 165 sites in 17 countries as follows: Argentina-3, Bulgaria-4, Canada-10, Croatia-4, Czech Republic-4, Germany-6, Greece-8, Italy-4, Poland-10, Republic of Korea-6, Romania-6, Russia-8, Serbia-9, Slovakia-5, Spain-8, Ukraine-6 and United States (US)-62. Two sites in the US screened but didn't randomise any subject.</recruitment_details>
      <pre_assignment_details>There was a 12-week run-in period primarily for optimisation of the basal insulin and reinforcement of subject training in trial procedures, diabetes education and dietary training. Out of the 1264 participants enrolled in the study, 173 were run-in failures and 1091 were randomised.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Faster Aspart</title>
          <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
        </group>
        <group group_id="P2">
          <title>NovoRapid</title>
          <description>Participants received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="546"/>
                <participants group_id="P2" count="545"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="546"/>
                <participants group_id="P2" count="545"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="544"/>
                <participants group_id="P2" count="544"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="531"/>
                <participants group_id="P2" count="531"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Faster Aspart</title>
          <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
        </group>
        <group group_id="B2">
          <title>NovoRapid</title>
          <description>Participants received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="546"/>
            <count group_id="B2" value="545"/>
            <count group_id="B3" value="1091"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.6" spread="8.6"/>
                    <measurement group_id="B2" value="62.1" spread="8.8"/>
                    <measurement group_id="B3" value="62.3" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="281"/>
                    <measurement group_id="B2" value="256"/>
                    <measurement group_id="B3" value="537"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="265"/>
                    <measurement group_id="B2" value="289"/>
                    <measurement group_id="B3" value="554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="487"/>
                    <measurement group_id="B2" value="487"/>
                    <measurement group_id="B3" value="974"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Ethnicity</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="485"/>
                    <measurement group_id="B2" value="488"/>
                    <measurement group_id="B3" value="973"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Glycosylated Haemoglobin (HbA1c)</title>
        <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glycosylated Haemoglobin (HbA1c)</title>
          <description>Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.62"/>
                    <measurement group_id="O2" value="-0.09" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, region and metformin use at baseline (Yes/No) as factors, and baseline HbA1c as a covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The upper limit of the 95% confidence interval for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4% non-inferiority was considered established and effect demonstrated.</non_inferiority_desc>
            <p_value>0.310</p_value>
            <method>ANOVA</method>
            <param_type>Treatment difference</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>Faster aspart-NovoRapid</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 1-hour PPG Increment</title>
        <description>Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 1-hour PPG Increment</title>
          <description>Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="519"/>
                <count group_id="O2" value="523"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="2.45"/>
                    <measurement group_id="O2" value="0.08" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 1,5-anhydroglucitol</title>
        <description>Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 1,5-anhydroglucitol</title>
          <description>Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="534"/>
                <count group_id="O2" value="531"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38" spread="3.10"/>
                    <measurement group_id="O2" value="0.89" spread="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG)</title>
        <description>Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG)</title>
          <description>Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="533"/>
                <count group_id="O2" value="530"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="2.38"/>
                    <measurement group_id="O2" value="0.68" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieved HbA1c &lt;7.0% (53 mmol/L) (Yes/No)</title>
        <description>Number of participants reaching HbA1c &lt;7.0% (53 mmol/L) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>16 weeks after randomisation</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieved HbA1c &lt;7.0% (53 mmol/L) (Yes/No)</title>
          <description>Number of participants reaching HbA1c &lt;7.0% (53 mmol/L) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="271"/>
                    <measurement group_id="O2" value="282"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="275"/>
                    <measurement group_id="O2" value="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieved HbA1c &lt;7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)</title>
        <description>Number of participants reaching HbA1c &lt;7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>16 weeks after randomisation</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieved HbA1c &lt;7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)</title>
          <description>Number of participants reaching HbA1c &lt;7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="265"/>
                    <measurement group_id="O2" value="278"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="281"/>
                    <measurement group_id="O2" value="267"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])</title>
        <description>Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])</title>
          <description>Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30-min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="519"/>
                    <count group_id="O2" value="522"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="2.90"/>
                    <measurement group_id="O2" value="0.55" spread="2.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="521"/>
                    <count group_id="O2" value="526"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="3.30"/>
                    <measurement group_id="O2" value="0.68" spread="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="519"/>
                    <count group_id="O2" value="524"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="3.96"/>
                    <measurement group_id="O2" value="0.61" spread="3.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="518"/>
                    <count group_id="O2" value="519"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="3.85"/>
                    <measurement group_id="O2" value="0.89" spread="3.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="514"/>
                    <count group_id="O2" value="519"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" spread="3.47"/>
                    <measurement group_id="O2" value="0.75" spread="3.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)</title>
        <description>Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)</title>
          <description>Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30-min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="518"/>
                    <count group_id="O2" value="519"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="1.85"/>
                    <measurement group_id="O2" value="-0.05" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="519"/>
                    <count group_id="O2" value="523"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="2.45"/>
                    <measurement group_id="O2" value="0.08" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="517"/>
                    <count group_id="O2" value="521"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.37" spread="3.25"/>
                    <measurement group_id="O2" value="0.001" spread="3.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="516"/>
                    <count group_id="O2" value="516"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="3.23"/>
                    <measurement group_id="O2" value="0.28" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="513"/>
                    <count group_id="O2" value="516"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="3.00"/>
                    <measurement group_id="O2" value="0.15" spread="3.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile</title>
        <description>Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-9-7 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile</title>
          <description>Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-9-7 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="454"/>
                <count group_id="O2" value="464"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="1.66"/>
                    <measurement group_id="O2" value="-0.50" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)</title>
        <description>Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)</title>
          <description>Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Breakfast</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="447"/>
                    <count group_id="O2" value="462"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="2.53"/>
                    <measurement group_id="O2" value="-0.28" spread="2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lunch</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="453"/>
                    <count group_id="O2" value="462"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="2.48"/>
                    <measurement group_id="O2" value="-0.58" spread="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Main evening meal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="447"/>
                    <count group_id="O2" value="459"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.04" spread="2.67"/>
                    <measurement group_id="O2" value="-0.71" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All meals</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="440"/>
                    <count group_id="O2" value="457"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.75" spread="1.89"/>
                    <measurement group_id="O2" value="-0.52" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)</title>
        <description>Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. PPG increment based on the 7-9-7-point profiles were derived separately for PG measurements made at 1 hour after main meals (breakfast, lunch and main evening meal). PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)</title>
          <description>Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. PPG increment based on the 7-9-7-point profiles were derived separately for PG measurements made at 1 hour after main meals (breakfast, lunch and main evening meal). PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Breakfast</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="447"/>
                    <count group_id="O2" value="461"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="2.23"/>
                    <measurement group_id="O2" value="-0.42" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lunch</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="453"/>
                    <count group_id="O2" value="460"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="2.69"/>
                    <measurement group_id="O2" value="-0.23" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Main evening meal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="444"/>
                    <count group_id="O2" value="459"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="2.61"/>
                    <measurement group_id="O2" value="-0.10" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All meals</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="438"/>
                    <count group_id="O2" value="455"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="1.55"/>
                    <measurement group_id="O2" value="-0.23" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile</title>
        <description>Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-9-7 point SMPG profile from baseline (week 0) after 16 weeks of randomisation (i.e., week 16). The results are presented as ratio to baseline. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile</title>
          <description>Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-9-7 point SMPG profile from baseline (week 0) after 16 weeks of randomisation (i.e., week 16). The results are presented as ratio to baseline. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="454"/>
                <count group_id="O2" value="464"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="48.32"/>
                    <measurement group_id="O2" value="0.85" spread="55.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements</title>
        <description>Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements</title>
          <description>Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bedtime to 04:00</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="343"/>
                    <count group_id="O2" value="347"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="4.09"/>
                    <measurement group_id="O2" value="0.29" spread="4.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bedtime to breakfast</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="419"/>
                    <count group_id="O2" value="438"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.30" spread="4.25"/>
                    <measurement group_id="O2" value="0.90" spread="3.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>04:00 to breakfast</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="355"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="2.76"/>
                    <measurement group_id="O2" value="0.75" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieved Overall PPG (1 Hour) &lt;7.8 mmol/L (140 mg/dL) (Yes/No)</title>
        <description>Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>16 weeks after randomisation</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieved Overall PPG (1 Hour) &lt;7.8 mmol/L (140 mg/dL) (Yes/No)</title>
          <description>Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="186"/>
                    <measurement group_id="O2" value="192"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="360"/>
                    <measurement group_id="O2" value="353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Who Achieved Overall PPG &lt;7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)</title>
        <description>Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>16 weeks after randomisation</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Who Achieved Overall PPG &lt;7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)</title>
          <description>Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="190"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="364"/>
                    <measurement group_id="O2" value="355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Bolus Insulin Dose: in Units/Day</title>
        <description>Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>16 weeks from randomisation</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Bolus Insulin Dose: in Units/Day</title>
          <description>Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Units/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="542"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.72" spread="35.82"/>
                    <measurement group_id="O2" value="53.38" spread="35.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Bolus Insulin Dose: in Units/kg/Day</title>
        <description>Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>16 weeks from randomisation</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Bolus Insulin Dose: in Units/kg/Day</title>
          <description>Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Units/kg/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="542"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread="0.33"/>
                    <measurement group_id="O2" value="0.55" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Basal Insulin Dose: in Units/Day</title>
        <description>Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>16 weeks from randomisation</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Basal Insulin Dose: in Units/Day</title>
          <description>Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Units/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="542"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.76" spread="35.21"/>
                    <measurement group_id="O2" value="62.25" spread="36.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Basal Insulin Dose: in Units/kg/Day</title>
        <description>Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>16 weeks from randomisation</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Basal Insulin Dose: in Units/kg/Day</title>
          <description>Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Units/kg/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="542"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="0.32"/>
                    <measurement group_id="O2" value="0.64" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Individual Meal Insulin Dose: in Units</title>
        <description>Individual meal time bolus insulin dose (Units) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>16 weeks from randomisation</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Individual Meal Insulin Dose: in Units</title>
          <description>Individual meal time bolus insulin dose (Units) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Breakfast</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="543"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.27" spread="12.04"/>
                    <measurement group_id="O2" value="15.52" spread="11.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lunch</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="543"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.51" spread="12.09"/>
                    <measurement group_id="O2" value="17.96" spread="11.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daily main evening meal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="542"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.88" spread="13.46"/>
                    <measurement group_id="O2" value="19.85" spread="14.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Individual Meal Insulin Dose: in Units/kg</title>
        <description>Individual meal time bolus insulin dose (Units/kg) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>16 weeks from randomisation</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Individual Meal Insulin Dose: in Units/kg</title>
          <description>Individual meal time bolus insulin dose (Units/kg) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Units/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Breakfast</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="543"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.12"/>
                    <measurement group_id="O2" value="0.16" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lunch</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="543"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.11"/>
                    <measurement group_id="O2" value="0.19" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daily main evening meal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="542"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.13"/>
                    <measurement group_id="O2" value="0.20" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline</title>
        <description>Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values are given as ratio to baseline (week 0) after 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline</title>
          <description>Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values are given as ratio to baseline (week 0) after 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.</description>
          <population>Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="542"/>
                    <count group_id="O2" value="537"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" spread="15.98"/>
                    <measurement group_id="O2" value="1.00" spread="17.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High density lipoproteins</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="542"/>
                    <count group_id="O2" value="537"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="14.47"/>
                    <measurement group_id="O2" value="0.98" spread="17.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low density lipoproteins</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="542"/>
                    <count group_id="O2" value="537"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="25.36"/>
                    <measurement group_id="O2" value="0.99" spread="40.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Adverse Events</title>
        <description>Number of treatment emergent adverse events were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Adverse Events</title>
          <description>Number of treatment emergent adverse events were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="667"/>
                    <measurement group_id="O2" value="643"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Injection Site Reactions</title>
        <description>Number of treatment emergent injection site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Injection Site Reactions</title>
          <description>Number of treatment emergent injection site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Number of injection site reactions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall</title>
        <description>ADA classification of hypos:&#xD;
Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.&#xD;
Documented symptomatic: PG ≤3.9 mmol/L with symptoms.&#xD;
Asymptomatic: PG ≤3.9 mmol/L without symptoms.&#xD;
Probable symptomatic: No measurement with symptoms.&#xD;
Pseudo: PG &gt;3.9 mmol/L with symptoms.&#xD;
Unclassifiable.&#xD;
NN classification of hypos:&#xD;
BG confirmed: PG &lt;3.1 mmol/L with/without symptoms.&#xD;
Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG &lt;3.1 mmol/L with symptoms.&#xD;
Severe or BG confirmed: Severe as per ADA and BG confirmed by PG &lt;3.1 mmol/L with/without symptoms.&#xD;
Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall</title>
          <description>ADA classification of hypos:&#xD;
Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.&#xD;
Documented symptomatic: PG ≤3.9 mmol/L with symptoms.&#xD;
Asymptomatic: PG ≤3.9 mmol/L without symptoms.&#xD;
Probable symptomatic: No measurement with symptoms.&#xD;
Pseudo: PG &gt;3.9 mmol/L with symptoms.&#xD;
Unclassifiable.&#xD;
NN classification of hypos:&#xD;
BG confirmed: PG &lt;3.1 mmol/L with/without symptoms.&#xD;
Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG &lt;3.1 mmol/L with symptoms.&#xD;
Severe or BG confirmed: Severe as per ADA and BG confirmed by PG &lt;3.1 mmol/L with/without symptoms.&#xD;
Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Number of hypoglycaemic episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Documented symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5038"/>
                    <measurement group_id="O2" value="6165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3761"/>
                    <measurement group_id="O2" value="3681"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Probable symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Pseudo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2209"/>
                    <measurement group_id="O2" value="2735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1490"/>
                    <measurement group_id="O2" value="2055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2227"/>
                    <measurement group_id="O2" value="2749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6806"/>
                    <measurement group_id="O2" value="7257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not able to selftreat - unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)</title>
        <description>Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)</title>
          <description>Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Number of hypoglycaemic episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Documented symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4703"/>
                    <measurement group_id="O2" value="5700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3617"/>
                    <measurement group_id="O2" value="3484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Probable symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Pseudo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2016"/>
                    <measurement group_id="O2" value="2442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1333"/>
                    <measurement group_id="O2" value="1814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2032"/>
                    <measurement group_id="O2" value="2454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6510"/>
                    <measurement group_id="O2" value="6875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not able to selftreat - unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)</title>
        <description>Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)</title>
          <description>Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Number of hypoglycaemic episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Documented symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="335"/>
                    <measurement group_id="O2" value="465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Probable symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Pseudo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="293"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="195"/>
                    <measurement group_id="O2" value="295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296"/>
                    <measurement group_id="O2" value="382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not able to selftreat - unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal</title>
        <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal</title>
          <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Number of hypoglycaemic episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Documented symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Probable symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Pseudo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not able to selftreat - unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal</title>
        <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal</title>
          <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Number of hypoglycaemic episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Documented symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="465"/>
                    <measurement group_id="O2" value="446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201"/>
                    <measurement group_id="O2" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Probable symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Pseudo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="233"/>
                    <measurement group_id="O2" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="181"/>
                    <measurement group_id="O2" value="212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235"/>
                    <measurement group_id="O2" value="247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="459"/>
                    <measurement group_id="O2" value="377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not able to selftreat - unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal</title>
        <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal</title>
          <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Number of hypoglycaemic episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Documented symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1627"/>
                    <measurement group_id="O2" value="1882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="852"/>
                    <measurement group_id="O2" value="744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Probable symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Pseudo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="762"/>
                    <measurement group_id="O2" value="965"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="557"/>
                    <measurement group_id="O2" value="820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="768"/>
                    <measurement group_id="O2" value="974"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1809"/>
                    <measurement group_id="O2" value="1714"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not able to selftreat - unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal</title>
        <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Weeks 0-16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal</title>
          <description>Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Number of hypoglycaemic episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Documented symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1162"/>
                    <measurement group_id="O2" value="1436"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="651"/>
                    <measurement group_id="O2" value="585"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Probable symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Pseudo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="529"/>
                    <measurement group_id="O2" value="719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="376"/>
                    <measurement group_id="O2" value="608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Severe or BG confirmed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="533"/>
                    <measurement group_id="O2" value="727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NN: Unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1350"/>
                    <measurement group_id="O2" value="1337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not able to selftreat - unclassifiable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physical Examination</title>
        <description>Participants with physical examination findings, normal, abnormal NCS (non- clinically significant) and abnormal CS (clinically significant) at baseline (week 0) and week 16 presented. Results are based on the data from the on-treatment observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system 2) Central &amp; Peripheral nervous system 3) Gastrointestinal system incl. mouth 4) Head, ears, eyes, nose, throat and neck 5) Musculoskeletal system 6) Respiratory system 7) Skin</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Examination</title>
          <description>Participants with physical examination findings, normal, abnormal NCS (non- clinically significant) and abnormal CS (clinically significant) at baseline (week 0) and week 16 presented. Results are based on the data from the on-treatment observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system 2) Central &amp; Peripheral nervous system 3) Gastrointestinal system incl. mouth 4) Head, ears, eyes, nose, throat and neck 5) Musculoskeletal system 6) Respiratory system 7) Skin</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cardiovascular system (week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="459"/>
                    <measurement group_id="O2" value="460"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular system (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="525"/>
                    <count group_id="O2" value="533"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="448"/>
                    <measurement group_id="O2" value="457"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central and Peripheral nervous sys. (week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="398"/>
                    <measurement group_id="O2" value="404"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                    <measurement group_id="O2" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central and Peripheral nervous sys. (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="525"/>
                    <count group_id="O2" value="533"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="383"/>
                    <measurement group_id="O2" value="400"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal sys. including mouth (Week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="491"/>
                    <measurement group_id="O2" value="485"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal sys. including mouth (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="525"/>
                    <count group_id="O2" value="533"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="480"/>
                    <measurement group_id="O2" value="476"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head, ears, eyes, nose, throat, neck (week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="498"/>
                    <measurement group_id="O2" value="492"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head, ears, eyes, nose, throat, neck (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="525"/>
                    <count group_id="O2" value="533"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="485"/>
                    <measurement group_id="O2" value="483"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculoskeletal system (week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="504"/>
                    <measurement group_id="O2" value="496"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculoskeletal system (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="525"/>
                    <count group_id="O2" value="533"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="489"/>
                    <measurement group_id="O2" value="494"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory system (week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="535"/>
                    <measurement group_id="O2" value="534"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory system (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="525"/>
                    <count group_id="O2" value="533"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="520"/>
                    <measurement group_id="O2" value="517"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin (week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="438"/>
                    <measurement group_id="O2" value="429"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="525"/>
                    <count group_id="O2" value="533"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="418"/>
                    <measurement group_id="O2" value="430"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure</title>
        <description>Change in vital signs - systolic and diastolic blood pressure from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure</title>
          <description>Change in vital signs - systolic and diastolic blood pressure from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="525"/>
                <count group_id="O2" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="14.0"/>
                    <measurement group_id="O2" value="-1.2" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="8.9"/>
                    <measurement group_id="O2" value="-0.7" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Signs: Pulse</title>
        <description>Change in vital signs - pulse from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Signs: Pulse</title>
          <description>Change in vital signs - pulse from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Beats per min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="525"/>
                <count group_id="O2" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="9.0"/>
                    <measurement group_id="O2" value="0.03" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Electrocardiogram (ECG)</title>
        <description>Changes in electrocardiogram (ECG) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Electrocardiogram (ECG)</title>
          <description>Changes in electrocardiogram (ECG) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="287"/>
                    <measurement group_id="O2" value="270"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="252"/>
                    <measurement group_id="O2" value="264"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="525"/>
                    <count group_id="O2" value="533"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="274"/>
                    <measurement group_id="O2" value="272"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="245"/>
                    <measurement group_id="O2" value="253"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fundoscopy/Fundus Photography</title>
        <description>Changes in fundoscopy/fundus photography from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fundoscopy/Fundus Photography</title>
          <description>Changes in fundoscopy/fundus photography from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="544"/>
                <count group_id="O2" value="544"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Left eye (week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="543"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="225"/>
                    <measurement group_id="O2" value="219"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="287"/>
                    <measurement group_id="O2" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left eye (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="514"/>
                    <count group_id="O2" value="516"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="205"/>
                    <measurement group_id="O2" value="198"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="278"/>
                    <measurement group_id="O2" value="288"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right eye (week 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="544"/>
                    <count group_id="O2" value="544"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="224"/>
                    <measurement group_id="O2" value="217"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="288"/>
                    <measurement group_id="O2" value="300"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right eye (week 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="514"/>
                    <count group_id="O2" value="517"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="208"/>
                    <measurement group_id="O2" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="276"/>
                    <measurement group_id="O2" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology - Haematocrit</title>
        <description>Changes in haematology - haematocrit from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology - Haematocrit</title>
          <description>Changes in haematology - haematocrit from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" spread="2.47"/>
                    <measurement group_id="O2" value="0.35" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology - Haemoglobin</title>
        <description>Changes in haematology - haemoglobin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology - Haemoglobin</title>
          <description>Changes in haematology - haemoglobin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.47"/>
                    <measurement group_id="O2" value="-0.04" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology - Leukocytes</title>
        <description>Changes in haematology - leukocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology - Leukocytes</title>
          <description>Changes in haematology - leukocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>10^9 leukocytes/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="1.60"/>
                    <measurement group_id="O2" value="-0.01" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology - Thrombocytes</title>
        <description>Changes in haematology - thrombocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology - Thrombocytes</title>
          <description>Changes in haematology - thrombocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>10^9 thrombocytes/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="531"/>
                <count group_id="O2" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="37.1"/>
                    <measurement group_id="O2" value="-1.3" spread="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology - Erythrocytes</title>
        <description>Changes in haematology - erythrocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology - Erythrocytes</title>
          <description>Changes in haematology - erythrocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>10^12 erythrocytes/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.28"/>
                    <measurement group_id="O2" value="-0.04" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)</title>
        <description>Changes in biochemistry - alanine aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)</title>
          <description>Changes in biochemistry - alanine aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="9.4"/>
                    <measurement group_id="O2" value="3.1" spread="65.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Alkaline Phosphatase</title>
        <description>Changes in biochemistry - alkaline phosphatase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Alkaline Phosphatase</title>
          <description>Changes in biochemistry - alkaline phosphatase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="22.6"/>
                    <measurement group_id="O2" value="2.2" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)</title>
        <description>Changes in biochemistry - aspratate aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)</title>
          <description>Changes in biochemistry - aspratate aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="7.9"/>
                    <measurement group_id="O2" value="2.2" spread="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Albumin</title>
        <description>Changes in biochemistry - albumin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Albumin</title>
          <description>Changes in biochemistry - albumin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.25"/>
                    <measurement group_id="O2" value="0.01" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Creatinine</title>
        <description>Changes in biochemistry - creatinine from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Creatinine</title>
          <description>Changes in biochemistry - creatinine from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="11.1"/>
                    <measurement group_id="O2" value="1.5" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Potassium</title>
        <description>Changes in biochemistry - potassium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Potassium</title>
          <description>Changes in biochemistry - potassium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.001" spread="0.50"/>
                    <measurement group_id="O2" value="0.02" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Sodium</title>
        <description>Changes in biochemistry - sodium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Sodium</title>
          <description>Changes in biochemistry - sodium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="2.6"/>
                    <measurement group_id="O2" value="-0.7" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Total Bilirubin</title>
        <description>Changes in biochemistry - total bilirubin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Total Bilirubin</title>
          <description>Changes in biochemistry - total bilirubin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="531"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="2.7"/>
                    <measurement group_id="O2" value="0.1" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemistry - Total Protein</title>
        <description>Changes in biochemistry - total protein from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemistry - Total Protein</title>
          <description>Changes in biochemistry - total protein from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="532"/>
                <count group_id="O2" value="536"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.35"/>
                    <measurement group_id="O2" value="-0.02" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight</title>
        <description>Changes in body weight from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight</title>
          <description>Changes in body weight from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="522"/>
                <count group_id="O2" value="530"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" spread="2.95"/>
                    <measurement group_id="O2" value="1.12" spread="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Mass Index (BMI)</title>
        <description>Change in the body mass index (BMI) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
        <time_frame>Week 0, week 16</time_frame>
        <population>Overall number of participants analyzed = number of participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Faster Aspart</title>
            <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
          <group group_id="O2">
            <title>NovoRapid</title>
            <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Mass Index (BMI)</title>
          <description>Change in the body mass index (BMI) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.</description>
          <population>Overall number of participants analyzed = number of participants with available data.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="522"/>
                <count group_id="O2" value="530"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="1.04"/>
                    <measurement group_id="O2" value="0.40" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Week 0 to Week 16 + 7 days. All reported adverse events (AEs) are treatment emergent (i.e., TEAE).</time_frame>
      <desc>All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of randomised treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Faster Aspart</title>
          <description>Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
        </group>
        <group group_id="E2">
          <title>NovoRapid</title>
          <description>Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (&lt; 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="544"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="544"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Cyclic vomiting syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Wrong product administered</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac stress test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="544"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Trigger finger</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic unconsciousness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Vascular parkinsonism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Rapid eye movements sleep abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Aortic valve replacement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Carpal tunnel decompression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Rehabilitation therapy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Vitrectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="544"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Subclavian vein occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
              <event>
                <sub_title>Varicose ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="544"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="544"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="35" subjects_affected="32" subjects_at_risk="544"/>
                <counts group_id="E2" events="36" subjects_affected="33" subjects_at_risk="544"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Reporting Anchor and Disclosure (1452)</name_or_title>
      <organization>Novo Nordisk A/S</organization>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268005
org study id: NN1218-4113
secondary id: U1111-1180-0636
secondary id: 2016-000878-38
nct id: NCT03268005
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new
      medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting
      insulin aspart will be tested to see how well it works and if it is safe. Participants will
      get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is
      decided by chance. Both medicines will be taken together with insulin degludec. Participants
      will need to take 1 injection 4 times every day (all insulins will be provided in pens). The
      study will last for about 8 months (34 weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
measure: Change in Glycosylated Haemoglobin (HbA1c)
time frame: Week 0, week 16
description: Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Change From Baseline in 1-hour PPG Increment
time frame: Week 0, week 16
description: Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Change From Baseline in 1,5-anhydroglucitol
time frame: Week 0, week 16
description: Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
time frame: Week 0, week 16
description: Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
time frame: 16 weeks after randomisation
description: Number of participants reaching HbA1c <7.0% (53 mmol/L) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)
time frame: 16 weeks after randomisation
description: Number of participants reaching HbA1c <7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])
time frame: Week 0, week 16
description: Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
measure: Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
time frame: Week 0, week 16
description: Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.
measure: Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile
time frame: Week 0, week 16
description: Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-9-7 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.
measure: Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
time frame: Week 0, week 16
description: Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
time frame: Week 0, week 16
description: Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. PPG increment based on the 7-9-7-point profiles were derived separately for PG measurements made at 1 hour after main meals (breakfast, lunch and main evening meal). PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile
time frame: Week 0, week 16
description: Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-9-7 point SMPG profile from baseline (week 0) after 16 weeks of randomisation (i.e., week 16). The results are presented as ratio to baseline. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements
time frame: Week 0, week 16
description: Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No)
time frame: 16 weeks after randomisation
description: Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)
time frame: 16 weeks after randomisation
description: Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Total Bolus Insulin Dose: in Units/Day
time frame: 16 weeks from randomisation
description: Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Total Bolus Insulin Dose: in Units/kg/Day
time frame: 16 weeks from randomisation
description: Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Total Basal Insulin Dose: in Units/Day
time frame: 16 weeks from randomisation
description: Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Total Basal Insulin Dose: in Units/kg/Day
time frame: 16 weeks from randomisation
description: Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Individual Meal Insulin Dose: in Units
time frame: 16 weeks from randomisation
description: Individual meal time bolus insulin dose (Units) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Individual Meal Insulin Dose: in Units/kg
time frame: 16 weeks from randomisation
description: Individual meal time bolus insulin dose (Units/kg) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline
time frame: Week 0, week 16
description: Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values are given as ratio to baseline (week 0) after 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
measure: Number of Treatment Emergent Adverse Events
time frame: Weeks 0-16
description: Number of treatment emergent adverse events were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Number of Treatment Emergent Injection Site Reactions
time frame: Weeks 0-16
description: Number of treatment emergent injection site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
time frame: Weeks 0-16
description: ADA classification of hypos:
Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.
Documented symptomatic: PG ≤3.9 mmol/L with symptoms.
Asymptomatic: PG ≤3.9 mmol/L without symptoms.
Probable symptomatic: No measurement with symptoms.
Pseudo: PG >3.9 mmol/L with symptoms.
Unclassifiable.
NN classification of hypos:
BG confirmed: PG <3.1 mmol/L with/without symptoms.
Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.
Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.
Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia.
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)
time frame: Weeks 0-16
description: Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
time frame: Weeks 0-16
description: Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal
time frame: Weeks 0-16
description: Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal
time frame: Weeks 0-16
description: Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal
time frame: Weeks 0-16
description: Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal
time frame: Weeks 0-16
description: Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Physical Examination
time frame: Week 0, week 16
description: Participants with physical examination findings, normal, abnormal NCS (non- clinically significant) and abnormal CS (clinically significant) at baseline (week 0) and week 16 presented. Results are based on the data from the on-treatment observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system 2) Central & Peripheral nervous system 3) Gastrointestinal system incl. mouth 4) Head, ears, eyes, nose, throat and neck 5) Musculoskeletal system 6) Respiratory system 7) Skin
measure: Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure
time frame: Week 0, week 16
description: Change in vital signs - systolic and diastolic blood pressure from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Vital Signs: Pulse
time frame: Week 0, week 16
description: Change in vital signs - pulse from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Electrocardiogram (ECG)
time frame: Week 0, week 16
description: Changes in electrocardiogram (ECG) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Fundoscopy/Fundus Photography
time frame: Week 0, week 16
description: Changes in fundoscopy/fundus photography from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Haematology - Haematocrit
time frame: Week 0, week 16
description: Changes in haematology - haematocrit from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Haematology - Haemoglobin
time frame: Week 0, week 16
description: Changes in haematology - haemoglobin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Haematology - Leukocytes
time frame: Week 0, week 16
description: Changes in haematology - leukocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Haematology - Thrombocytes
time frame: Week 0, week 16
description: Changes in haematology - thrombocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Haematology - Erythrocytes
time frame: Week 0, week 16
description: Changes in haematology - erythrocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)
time frame: Week 0, week 16
description: Changes in biochemistry - alanine aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Alkaline Phosphatase
time frame: Week 0, week 16
description: Changes in biochemistry - alkaline phosphatase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)
time frame: Week 0, week 16
description: Changes in biochemistry - aspratate aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Albumin
time frame: Week 0, week 16
description: Changes in biochemistry - albumin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Creatinine
time frame: Week 0, week 16
description: Changes in biochemistry - creatinine from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Potassium
time frame: Week 0, week 16
description: Changes in biochemistry - potassium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Sodium
time frame: Week 0, week 16
description: Changes in biochemistry - sodium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Total Bilirubin
time frame: Week 0, week 16
description: Changes in biochemistry - total bilirubin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Biochemistry - Total Protein
time frame: Week 0, week 16
description: Changes in biochemistry - total protein from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Body Weight
time frame: Week 0, week 16
description: Changes in body weight from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
measure: Change From Baseline in Body Mass Index (BMI)
time frame: Week 0, week 16
description: Change in the body mass index (BMI) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
arm group label: Faster aspart + insulin degludec with or without metformin
arm group type: Experimental
arm group label: NovoRapid/NovoLog + insulin degludec with or without metformin
arm group type: Active Comparator
intervention type: Drug
intervention name: Faster-acting insulin aspart
description: Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
arm group label: Faster aspart + insulin degludec with or without metformin
intervention type: Drug
intervention name: Insulin aspart
description: Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
arm group label: NovoRapid/NovoLog + insulin degludec with or without metformin
intervention type: Drug
intervention name: Insulin degludec
description: Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
arm group label: Faster aspart + insulin degludec with or without metformin
arm group label: NovoRapid/NovoLog + insulin degludec with or without metformin
intervention type: Drug
intervention name: Metformin
description: Only participants who took metformin before the study should take metformin tablets, same dose as before the study
arm group label: Faster aspart + insulin degludec with or without metformin
arm group label: NovoRapid/NovoLog + insulin degludec with or without metformin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Bulgaria
country: Canada
country: Croatia
country: Czechia
country: Germany
country: Greece
country: Italy
country: Korea, Republic of
country: Poland
country: Puerto Rico
country: Romania
country: Russian Federation
country: Serbia
country: Slovakia
country: Spain
country: Ukraine
country: United States
citation: Lane WS, Favaro E, Rathor N, Jang HC, Kjaersgaard MIS, Oviedo A, Rose L, Senior P, Sesti G, Soto Gonzalez A, Franek E. A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9). Diabetes Care. 2020 Aug;43(8):1710-1716. doi: 10.2337/dc19-2232. Epub 2020 Mar 24.
PMID: 32209647
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Metformin
mesh term: Insulin Aspart
mesh term: Insulin, Long-Acting
mesh term: Insulin degludec, insulin aspart drug combination
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 