<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    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/NCT02987751</url>
  </required_header>
  <id_info>
    <org_study_id>IDRFARH007</org_study_id>
    <nct_id>NCT02987751</nct_id>
  </id_info>
  <brief_title>A Study on Comparison of Glargine Plus Glulisine With Premixed Insulin in Type 2 Diabetes Patients</brief_title>
  <official_title>A Prospective, Multicentric, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog Glargine Plus Glulisine With Premixed Insulin in Adult Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>India Diabetes Research Foundation &amp; Dr. A. Ramachandran's Diabetes Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>India Diabetes Research Foundation &amp; Dr. A. Ramachandran's Diabetes Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal&#xD;
      Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2&#xD;
      Diabetes Mellitus in 200 patients that will be conducted in seven centers in Tamil Nadu. The&#xD;
      primary outcome measures will be to compare the change in HbA1c from baseline to week 24&#xD;
      between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin&#xD;
      naïve patients with T2DM. The secondary outcomes is to compare the following in the two arms&#xD;
      between baseline and 24 weeks Fasting plasma glucose, Postprandial glucose, 7-point&#xD;
      self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c &lt; 7%,&#xD;
      Insulin dose, Overall adverse events, Symptomatic Hypoglycemia, Severe hypoglycemic, Weight,&#xD;
      BMI and Blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will be invited to the study centre from the local population who are willing to&#xD;
      participate in the trial. Each subject will be informed both orally and in writing about the&#xD;
      study prior to inclusion in the study and only the subjects who give written informed consent&#xD;
      will be included. The selection of the subjects is based on the inclusion and exclusion&#xD;
      criteria defined in the protocol. The selected subjects will be given a screening number and&#xD;
      subjected to screening procedure to find out eligible candidates for enrollment. The&#xD;
      screening procedure includes obtaining subject's anthropometric data, baseline&#xD;
      symptomatology, medical history, vital signs, physical examination, laboratory investigations&#xD;
      like blood glucose (fasting &amp; 2hr after meal), HbA1c, Urea, Creatinine, Liver function test,&#xD;
      Lipid profile, Urine albumin/creatinine ratio, urine pregnancy (if applicable) and ECG.&#xD;
&#xD;
      This will be followed by 2 weeks run in period for eligible patients to ensure patients are&#xD;
      on stable dose of oral therapy and Metformin not &lt; 1500 mg/day. Sulfonylurea will be stopped.&#xD;
&#xD;
      All the eligible patients as per the inclusion criteria (HbA1c ≥7.5% to ≤ 10.5%, fasting&#xD;
      blood glucose ≥ 150 mg/dl, and/or Postprandial blood glucose ≥ 200 mg/dl) will be randomized&#xD;
      in two arms. Participants in arm-1 will receive once daily insulin Glargine (12 units) plus&#xD;
      once daily Glulisine (4 units) at breakfast/dinner, along with OHAs at stable dose and&#xD;
      titrated optimally. Participants in the arm-2 will receive once daily premix analogue insulin&#xD;
      (30/70) 16 units at breakfast/dinner, along with OHAs at stable dose and will be titrated as&#xD;
      per the treatment algorithm.&#xD;
&#xD;
      During the randomization visit, the selected subjects after the run in period will be given a&#xD;
      subject number and randomized between two arms.&#xD;
&#xD;
      Anthropometric measurements and vital sign will be taken. Concomitant medication and adverse&#xD;
      events will be noted. Glucose meter, strips, Insulin and study diary will be dispensed.&#xD;
      Training on Glucose meter usage, hypoglycemia, hyperglycemia symptoms, Insulin injection&#xD;
      technique and dose titration technique will be done. Subjects will be instructed to maintain&#xD;
      the record of dosing details in the patient diary. They will be given Diet and Exercise&#xD;
      counselling. They will be asked to hand over the study diary and Insulin pen (empty or full)&#xD;
      to the coordinator at each visit.&#xD;
&#xD;
      First three months will be an insulin dose titration period in which the subjects will be&#xD;
      asked to visit the clinic at 12 weeks. Telephonic visit at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10&#xD;
      and 11. At week 4, and 8 investigator can have an unscheduled visit for training or insulin&#xD;
      dispensing. During the telephonic visit subjects will be asked about concomitant medication&#xD;
      and adverse events. During clinic visit at 12 weeks or unscheduled visit at week 4 or 8&#xD;
      anthropometric measurements, vital signs, concomitant medication and adverse event will be&#xD;
      recorded. Glucometer strips, Insulin and study diary will be dispensed. The Insulin and study&#xD;
      diary given during previous visit will be collected. The dose of Insulin will be titrated&#xD;
      according to the algorithm given in appendix below with the 7 point SMBG done by the subject&#xD;
      ±5 days before the following weeks 4, 8 &amp; 12 and also insulin dose can be titrated by finger&#xD;
      prick FBS and PPBS done at week 2, 6 and 10.&#xD;
&#xD;
      After 3 months, participants in arm-1 may undergo intensification to 2 injections of&#xD;
      Glulisine if HbA1c is &gt; 7% and/or 2-h postprandial glucose is &gt;140 mg/dL. After 3 months,&#xD;
      participants in arm-2 premix OD can be made BD if HbA1c is &gt; 7% and/or 2-h postprandial&#xD;
      glucose is &gt;140 mg/dL despite effective titration of existing doses.&#xD;
&#xD;
      The next three months will be an insulin dose maintenance period in which the subjects will&#xD;
      be asked to visit the clinic at 24 week. At week 16 and 20 telephonic visit or an unscheduled&#xD;
      visit will be performed. During the telephonic visit they will be asked about concomitant&#xD;
      medication and adverse events. During clinic visit at 24 weeks or unscheduled visit at week&#xD;
      16 or 20, anthropometric measurements, vital signs, concomitant medication and adverse event&#xD;
      will be recorded. Glucometer strips, Insulin and study diary will be dispensed. The Insulin&#xD;
      and study diary given during previous visit will be collected. The dose of Insulin, if needed&#xD;
      will be titrated according to algorithm given in appendix below with the 7 point SMBG done by&#xD;
      the subjects ±5 days before the following week 16, week 20 and week 24.&#xD;
&#xD;
      During the clinic visit at weeks 12 and 24, Medical history, Physical examination, laboratory&#xD;
      investigations like blood glucose (fasting &amp; 2hr after meal), HbA1c, Urea, Creatinine, Liver&#xD;
      function test, Lipid profile, Urine albumin/creatinine ratio, urine pregnancy (if applicable)&#xD;
      and ECG at week 24 will be done.&#xD;
&#xD;
      During the end of study visit at week 24 the subject will undergo medical examination,&#xD;
      anthropometric measurements, vital signs, concomitant medication and adverse event will be&#xD;
      recorded. The Insulin and study diary given during previous visit will be collected.&#xD;
&#xD;
      Subjects experiencing any hypoglycemia should inform the coordinator or the investigator over&#xD;
      the phone and make an unscheduled visit. In case they experience adverse event should inform&#xD;
      the coordinator or the investigator over the phone and make an unscheduled visit as per&#xD;
      investigator's discretion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in HbA1c</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>To compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Fasting Blood Glucose</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in fasting blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in postprandial blood glucose</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in postprandial blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 7 point self monitored blood glucose profile</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in 7 point self monitored blood glucose profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage reduction of HbA1c &lt; 7%</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of percentage reduction of HbA1c &lt; 7%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Insulin dose</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in Insulin dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of events of symptomatic hypoglycemia</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of number of events of symptomatic hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of events of severe hypoglycemia</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of number of events of severe hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in Weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Body mass index</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants treated related to adverse events</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Number of adverse event observed in both Glargine + Glulisine and Premixed analogue Insulin group will be assessed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Glargine + Glulisine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin Glargine + Glulisine (12U/day + 4U/day) at pre-breakfast/dinner for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Premixed Analogue Insulin (70/30)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Premixed analogue Insulin (70/30) 16U/day at pre-breakfast/dinner for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glargine + Glulisine</intervention_name>
    <description>Glargine should be taken 30 minutes before breakfast/dinner, the dose is adjusted as per fasting blood glucose during each visit and Glulisine should be taken 20 minutes before breakfast/dinner, the dose is adjusted as per postprandial blood glucose during each visit</description>
    <arm_group_label>Glargine + Glulisine</arm_group_label>
    <other_name>Lantus + Apidra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Premixed analogue insulin (70/30)</intervention_name>
    <description>Premixed analogue insulin should be taken 30 minutes before breakfast/dinner, the dose is adjusted as per fasting blood glucose during each visit.</description>
    <arm_group_label>Premixed Analogue Insulin (70/30)</arm_group_label>
    <other_name>Novomix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Insulin naïve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3&#xD;
             months.&#xD;
&#xD;
          2. Both men and women of age ≥ 18 and ≤ 65 years.&#xD;
&#xD;
          3. Have an HbA1c ≥ 7.5% and ≤ 10.5% with fasting blood glucose ≥ 150 mg/dl, and/or&#xD;
             Postprandial blood glucose ≥ 200 mg/dl&#xD;
&#xD;
          4. Body mass index (BMI) ≤ 40 kg/m2.&#xD;
&#xD;
          5. Have given written informed consent to participate in this study in accordance with&#xD;
             local regulations.&#xD;
&#xD;
          6. Subject must have access to telephone for calling into the clinical center as part of&#xD;
             test product compliance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Type 1 diabetes&#xD;
&#xD;
          2. BMI &gt; 40 kg/m2&#xD;
&#xD;
          3. Subject is being treated for severe active infection of any type&#xD;
&#xD;
          4. Have had more than one episode of severe hypoglycemia within 6 months prior to entry&#xD;
             into the study.&#xD;
&#xD;
          5. Planned surgery in the next 6 months&#xD;
&#xD;
          6. Any event forecasted to require a temporary need to switch to insulin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ambady Ramachandran, MD,Ph.D,D.Sc</last_name>
    <role>Principal Investigator</role>
    <affiliation>President, India Diabetes Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr.Mallikarjnn Jali</name>
      <address>
        <city>Belgaum</city>
        <state>Karnataka</state>
        <zip>590010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singhvi Health Centre</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600 019</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedWay Hospitals</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600024</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kovai Diabetes Speciality Center and Hospital</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamil Nadu</state>
        <zip>641009</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthur Asirvatham Hospital</name>
      <address>
        <city>Madurai</city>
        <state>Tamil Nadu</state>
        <zip>625 020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.G.Diabetes Speciality and Research Center</name>
      <address>
        <city>Salem</city>
        <state>Tamil Nadu</state>
        <zip>636016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ramana Maharishi Rangammal Hospital</name>
      <address>
        <city>Tiruvannamalai</city>
        <state>Tamil Nadu</state>
        <zip>606 603</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trichy Diabetes Speciality Center (P) Ltd</name>
      <address>
        <city>Trichy</city>
        <state>Tamil Nadu</state>
        <zip>620018</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</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 Glargine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02987751
org study id: IDRFARH007
nct id: NCT02987751
lead sponsor: 
has dmc: Yes
This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal
      Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2
      Diabetes Mellitus in 200 patients that will be conducted in seven centers in Tamil Nadu. The
      primary outcome measures will be to compare the change in HbA1c from baseline to week 24
      between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin
      naïve patients with T2DM. The secondary outcomes is to compare the following in the two arms
      between baseline and 24 weeks Fasting plasma glucose, Postprandial glucose, 7-point
      self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%,
      Insulin dose, Overall adverse events, Symptomatic Hypoglycemia, Severe hypoglycemic, Weight,
      BMI and Blood pressure.
The subjects will be invited to the study centre from the local population who are willing to
      participate in the trial. Each subject will be informed both orally and in writing about the
      study prior to inclusion in the study and only the subjects who give written informed consent
      will be included. The selection of the subjects is based on the inclusion and exclusion
      criteria defined in the protocol. The selected subjects will be given a screening number and
      subjected to screening procedure to find out eligible candidates for enrollment. The
      screening procedure includes obtaining subject's anthropometric data, baseline
      symptomatology, medical history, vital signs, physical examination, laboratory investigations
      like blood glucose (fasting & 2hr after meal), HbA1c, Urea, Creatinine, Liver function test,
      Lipid profile, Urine albumin/creatinine ratio, urine pregnancy (if applicable) and ECG.

      This will be followed by 2 weeks run in period for eligible patients to ensure patients are
      on stable dose of oral therapy and Metformin not < 1500 mg/day. Sulfonylurea will be stopped.

      All the eligible patients as per the inclusion criteria (HbA1c ≥7.5% to ≤ 10.5%, fasting
      blood glucose ≥ 150 mg/dl, and/or Postprandial blood glucose ≥ 200 mg/dl) will be randomized
      in two arms. Participants in arm-1 will receive once daily insulin Glargine (12 units) plus
      once daily Glulisine (4 units) at breakfast/dinner, along with OHAs at stable dose and
      titrated optimally. Participants in the arm-2 will receive once daily premix analogue insulin
      (30/70) 16 units at breakfast/dinner, along with OHAs at stable dose and will be titrated as
      per the treatment algorithm.

      During the randomization visit, the selected subjects after the run in period will be given a
      subject number and randomized between two arms.

      Anthropometric measurements and vital sign will be taken. Concomitant medication and adverse
      events will be noted. Glucose meter, strips, Insulin and study diary will be dispensed.
      Training on Glucose meter usage, hypoglycemia, hyperglycemia symptoms, Insulin injection
      technique and dose titration technique will be done. Subjects will be instructed to maintain
      the record of dosing details in the patient diary. They will be given Diet and Exercise
      counselling. They will be asked to hand over the study diary and Insulin pen (empty or full)
      to the coordinator at each visit.

      First three months will be an insulin dose titration period in which the subjects will be
      asked to visit the clinic at 12 weeks. Telephonic visit at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
      and 11. At week 4, and 8 investigator can have an unscheduled visit for training or insulin
      dispensing. During the telephonic visit subjects will be asked about concomitant medication
      and adverse events. During clinic visit at 12 weeks or unscheduled visit at week 4 or 8
      anthropometric measurements, vital signs, concomitant medication and adverse event will be
      recorded. Glucometer strips, Insulin and study diary will be dispensed. The Insulin and study
      diary given during previous visit will be collected. The dose of Insulin will be titrated
      according to the algorithm given in appendix below with the 7 point SMBG done by the subject
      ±5 days before the following weeks 4, 8 & 12 and also insulin dose can be titrated by finger
      prick FBS and PPBS done at week 2, 6 and 10.

      After 3 months, participants in arm-1 may undergo intensification to 2 injections of
      Glulisine if HbA1c is > 7% and/or 2-h postprandial glucose is >140 mg/dL. After 3 months,
      participants in arm-2 premix OD can be made BD if HbA1c is > 7% and/or 2-h postprandial
      glucose is >140 mg/dL despite effective titration of existing doses.

      The next three months will be an insulin dose maintenance period in which the subjects will
      be asked to visit the clinic at 24 week. At week 16 and 20 telephonic visit or an unscheduled
      visit will be performed. During the telephonic visit they will be asked about concomitant
      medication and adverse events. During clinic visit at 24 weeks or unscheduled visit at week
      16 or 20, anthropometric measurements, vital signs, concomitant medication and adverse event
      will be recorded. Glucometer strips, Insulin and study diary will be dispensed. The Insulin
      and study diary given during previous visit will be collected. The dose of Insulin, if needed
      will be titrated according to algorithm given in appendix below with the 7 point SMBG done by
      the subjects ±5 days before the following week 16, week 20 and week 24.

      During the clinic visit at weeks 12 and 24, Medical history, Physical examination, laboratory
      investigations like blood glucose (fasting & 2hr after meal), HbA1c, Urea, Creatinine, Liver
      function test, Lipid profile, Urine albumin/creatinine ratio, urine pregnancy (if applicable)
      and ECG at week 24 will be done.

      During the end of study visit at week 24 the subject will undergo medical examination,
      anthropometric measurements, vital signs, concomitant medication and adverse event will be
      recorded. The Insulin and study diary given during previous visit will be collected.

      Subjects experiencing any hypoglycemia should inform the coordinator or the investigator over
      the phone and make an unscheduled visit. In case they experience adverse event should inform
      the coordinator or the investigator over the phone and make an unscheduled visit as per
      investigator's discretion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in HbA1c
time frame: Baseline and 24 weeks
description: To compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DM
measure: Changes in Fasting Blood Glucose
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in fasting blood glucose
measure: Changes in postprandial blood glucose
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in postprandial blood glucose
measure: Changes in 7 point self monitored blood glucose profile
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in 7 point self monitored blood glucose profile
measure: Percentage reduction of HbA1c < 7%
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of percentage reduction of HbA1c < 7%
measure: Changes in Insulin dose
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in Insulin dose
measure: Number of events of symptomatic hypoglycemia
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of number of events of symptomatic hypoglycemia
measure: Number of events of severe hypoglycemia
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of number of events of severe hypoglycemia
measure: Changes in weight
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in Weight
measure: Changes in Body mass index
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in body mass index
measure: Changes in blood pressure
time frame: Baseline and 24 weeks
description: Effect of Glargine + Glulisine versus Premixed analogue Insulin in terms of changes in blood pressure
measure: Number of participants treated related to adverse events
time frame: Baseline and 24 weeks
description: Number of adverse event observed in both Glargine + Glulisine and Premixed analogue Insulin group will be assessed
arm group label: Glargine + Glulisine
arm group type: Experimental
description: Insulin Glargine + Glulisine (12U/day + 4U/day) at pre-breakfast/dinner for 24 weeks
arm group label: Premixed Analogue Insulin (70/30)
arm group type: Active Comparator
description: Premixed analogue Insulin (70/30) 16U/day at pre-breakfast/dinner for 24 weeks
intervention type: Drug
intervention name: Glargine + Glulisine
description: Glargine should be taken 30 minutes before breakfast/dinner, the dose is adjusted as per fasting blood glucose during each visit and Glulisine should be taken 20 minutes before breakfast/dinner, the dose is adjusted as per postprandial blood glucose during each visit
arm group label: Glargine + Glulisine
other name: Lantus + Apidra
intervention type: Drug
intervention name: Premixed analogue insulin (70/30)
description: Premixed analogue insulin should be taken 30 minutes before breakfast/dinner, the dose is adjusted as per fasting blood glucose during each visit.
arm group label: Premixed Analogue Insulin (70/30)
other name: Novomix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ambady Ramachandran, MD,Ph.D,D.Sc
role: Principal Investigator
affiliation: President, India Diabetes Research Foundation
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country: India
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin Glargine
sharing ipd: Undecided