<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/NCT03830281</url>
  </required_header>
  <id_info>
    <org_study_id>16315</org_study_id>
    <secondary_id>I8B-MC-ITRO</secondary_id>
    <secondary_id>2015-005358-36</secondary_id>
    <nct_id>NCT03830281</nct_id>
  </id_info>
  <brief_title>A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy</brief_title>
  <acronym>PRONTO-Pump-2</acronym>
  <official_title>A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</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 reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)&#xD;
      when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">January 6, 2020</completion_date>
  <primary_completion_date type="Actual">January 6, 2020</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Severe Hypoglycemia at Week 16</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Documented Symptomatic Hypoglycemia at Week 16</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of &lt;54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, HbA1c stratum : less than or equal to (≤)7.5%, greater than (&gt;)7.5% and participant's personal CGM or FGM use during the study), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Insulin Dose at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HbA1c &lt;7%</measure>
    <time_frame>Week 16</time_frame>
    <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia &gt;300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change</measure>
    <time_frame>Baseline through Week 16</time_frame>
    <description>Percentage of participants with at least 1 event of unexplained hyperglycemia &gt;300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">471</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Insulin Lispro (Humalog)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultra-Rapid Lispro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received individual dose of 100 units per milliliter (U/mL) ultra rapid lispro by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ultra-Rapid Lispro</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Ultra-Rapid Lispro</arm_group_label>
    <other_name>LY900014</other_name>
    <other_name>Insulin lispro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Lispro</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Insulin Lispro (Humalog)</arm_group_label>
    <other_name>Humalog</other_name>
    <other_name>LY275585</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have been diagnosed with T1D and continuously using insulin for at least 1 year&#xD;
&#xD;
          -  Have been using CSII therapy for a minimum of 6 months&#xD;
&#xD;
          -  Currently treated with &lt;100 Units of one of following rapid-acting analog insulin via&#xD;
             CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting&#xD;
             insulin aspart, insulin glulisine&#xD;
&#xD;
          -  Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and&#xD;
             Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump&#xD;
             for at least the past 90 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have hypoglycemia unawareness&#xD;
&#xD;
          -  Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening&#xD;
&#xD;
          -  Have had more than 1 emergency room visit or hospitalization due to poor glucose&#xD;
             control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Muir Physician Network Clinical Research Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Research</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin Endocrine Associates</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes and Endocrine Associates</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Valley Medical Group</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center of Excellence in Diabetes &amp; Endocrinology</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Investigators, Inc.</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Metabolic Research Centre</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Davis Center for Childhood Diabetes</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ALL Medical Research, LLC</name>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Coast Clinical Research, Inc</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metabolic Research Institute Inc.</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Diabetes Associates</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrine Research Solutions, Inc.</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East West Medical Institute</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Diabetes and Osteoporosis Center</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prairie Education and Research Cooperative</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iderc, P.L.C.</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Diabetes Endocrinology Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrine and Metabolic Consultants</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Research Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Research Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern New Hampshire Diabetes and Endocrinology</name>
      <address>
        <city>Nashua</city>
        <state>New Hampshire</state>
        <zip>03063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians East</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27843</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes and Endocrinology-Austin South</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78749</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Diabetes Endocrine Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes and Endocrinology, P.A.</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private: Dr. Larry Stonesifer</name>
      <address>
        <city>Federal Way</city>
        <state>Washington</state>
        <zip>98003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Clinical Research Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tacoma Center for Arthritis Research, PS</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The AIM Centre</name>
      <address>
        <city>Merewether</city>
        <state>New South Wales</state>
        <zip>2291</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GP Plus Marion</name>
      <address>
        <city>Oaklands Park</city>
        <state>South Australia</state>
        <zip>5046</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barwon Health - The Geelong Hospital</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fremantle Hospital</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Graz</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VIVIT Institut am LKH Feldkirch</name>
      <address>
        <city>Feldkirch</city>
        <state>Vorarlberg</state>
        <zip>6800</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KA Rudolfstiftung</name>
      <address>
        <city>Vienna</city>
        <zip>1030</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMC Endocrinology Centres Ltd.</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4N 7L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMC Endocrinology Centres Ltd.</name>
      <address>
        <city>Concord</city>
        <state>Ontario</state>
        <zip>L4K 4M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMC Endocrinology Centres</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6M 4H8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMC Endocrinology Centres Ltd.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCM</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W 1R7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMC Endocrinology Centres Ltd.</name>
      <address>
        <city>Ville St-Laurent</city>
        <state>Quebec</state>
        <zip>H4T 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse Hopital de Rangueil</name>
      <address>
        <city>Toulouse</city>
        <state>Cedex 9</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Hotel Dieu</name>
      <address>
        <city>Le Creusot</city>
        <zip>71200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier universitaire Lapeyronie</name>
      <address>
        <city>Montpellier Cedex 5</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Cochin</name>
      <address>
        <city>Paris CEDEX 14</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de HautePierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe hospitalier mutualiste Les Portes du sud</name>
      <address>
        <city>Venissieux</city>
        <zip>69200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arztpraxis Dr. Cornelia Marck</name>
      <address>
        <city>Pohlheim</city>
        <state>Hessen</state>
        <zip>35415</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut für Diabetesforschung Münster GmbH</name>
      <address>
        <city>Münster</city>
        <state>Nordrhein-Westfalen</state>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Kempe - Dr. Stemler</name>
      <address>
        <city>Ludwigshafen am Rhein</city>
        <state>Rheinland-Pfalz</state>
        <zip>67059</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwerpunktpraxis Diabetes</name>
      <address>
        <city>Saint Ingbert-Oberwürzbach</city>
        <state>Saarland</state>
        <zip>66386</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RED-Institut GmbH</name>
      <address>
        <city>Oldenburg</city>
        <state>Schleswig-Holstein</state>
        <zip>23758</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetespraxis Prenzlauer Allee</name>
      <address>
        <city>Berlin</city>
        <zip>10409</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen</name>
      <address>
        <city>Hamburg</city>
        <zip>21073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis für innere Medizin und Diabetologie</name>
      <address>
        <city>Hamburg</city>
        <zip>22607</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budai Irgalmasrendi Korhaz</name>
      <address>
        <city>Budapest</city>
        <zip>1023</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinDiab Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1089</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNO Medical Trials Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1135</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TRANTOR 99 Bt.</name>
      <address>
        <city>Budapest</city>
        <zip>1213</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center - Pediatric Outpatient Clinic</name>
      <address>
        <city>Beer-Sheva</city>
        <zip>8410101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schneider Medical Center</name>
      <address>
        <city>Petah Tiqva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5266202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <zip>24128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giovanni di Dio</name>
      <address>
        <city>Olbia</city>
        <zip>07026</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria delle Croci</name>
      <address>
        <city>Ravenna</city>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research, LLC</name>
      <address>
        <city>Bayamon</city>
        <zip>00961</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Endocrinologia Alcantara Gonzalez</name>
      <address>
        <city>Lomas Verdes</city>
        <zip>00956</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporació Sanitaria Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Arnau de Vilanova</name>
      <address>
        <city>Lleida</city>
        <state>Cataluña</state>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic I Provincial</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.lillytrialguide.com/en-US/studies/type-1-diabetes/ITRO#?postal=</url>
    <description>A Study Comparing LY900014 to Insulin Lispro in Adults With Type 1 Diabetes Using Insulin Pump Therapy</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <results_first_submitted>January 4, 2021</results_first_submitted>
  <results_first_submitted_qc>January 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 22, 2021</results_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</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 1</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>Insulin Lispro</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>http://vivli.org/</ipd_url>
  </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>October 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03830281/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>January 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03830281/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The purpose of the lead-in period was to assess basal rates and bolus calculator settings and adjust if needed prior to randomization. Participants (Pts) were then randomized to insulin lispro (Humalog) or ultra-rapid lispro as both basal and bolus insulin and delivered bolus doses 0 to 2 minutes prior to each meal (pre-meal).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Insulin Lispro (Humalog)</title>
          <description>Participants received individual dose of 100 units per milliliter (U/mL) insulin lispro (Humalog) by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
        </group>
        <group group_id="P2">
          <title>Ultra-Rapid Lispro</title>
          <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Lead-in Period (2 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="471"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="432"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not Met Eligibility Criteria</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period (16 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="217">Pts who completed lead-in period randomized to Humalog or Ultra-Rapid Lispro in treatment period.</participants>
                <participants group_id="P2" count="215">Pts who completed lead-in period randomized to Humalog or Ultra-Rapid Lispro in treatment period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="205"/>
                <participants group_id="P2" count="198"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Insulin Lispro (Humalog)</title>
          <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
        </group>
        <group group_id="B2">
          <title>Ultra-Rapid Lispro</title>
          <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</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="217"/>
            <count group_id="B2" value="215"/>
            <count group_id="B3" value="432"/>
          </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="44.7" spread="14.9"/>
                    <measurement group_id="B2" value="48.2" spread="15.4"/>
                    <measurement group_id="B3" value="46.4" spread="15.3"/>
                  </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="119"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                    <measurement group_id="B2" value="178"/>
                    <measurement group_id="B3" value="358"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="207"/>
                    <measurement group_id="B2" value="202"/>
                    <measurement group_id="B3" value="409"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Puerto Rico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c</title>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.54" spread="0.58"/>
                    <measurement group_id="B2" value="7.56" spread="0.59"/>
                    <measurement group_id="B3" value="7.55" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16</title>
        <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline HbA1c data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16</title>
          <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
          <population>All randomized participants with baseline and at least one post-baseline HbA1c data.</population>
          <units>Percentage of HbA1c</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="207"/>
                <count group_id="O2" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.030"/>
                    <measurement group_id="O2" value="-0.06" spread="0.031"/>
                  </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>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Noninferiority margin = 0.4% for HbA1c</non_inferiority_desc>
            <p_value>0.565</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.06</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16</title>
        <description>A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline 1-hour PPG data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16</title>
          <description>A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
          <population>All randomized participants with baseline and at least one post-baseline 1-hour PPG data.</population>
          <units>milligrams per deciliter (mg/dL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="5.02"/>
                    <measurement group_id="O2" value="-26.3" spread="5.33"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-24.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.0</ci_lower_limit>
            <ci_upper_limit>-12.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16</title>
        <description>A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline 2-hour PPG data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16</title>
          <description>A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.</description>
          <population>All randomized participants with baseline and at least one post-baseline 2-hour PPG data.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
                <count group_id="O2" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="6.27"/>
                    <measurement group_id="O2" value="-32.0" spread="6.59"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-27.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.6</ci_lower_limit>
            <ci_upper_limit>-13.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16</title>
        <description>Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares).</description>
        <time_frame>Week 16</time_frame>
        <population>All randomized participants with non-missing baseline value and at least one non-missing post-baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16</title>
          <description>Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares).</description>
          <population>All randomized participants with non-missing baseline value and at least one non-missing post-baseline value.</population>
          <units>percentage of time</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Daytime</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="181"/>
                    <count group_id="O2" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.6" spread="0.75"/>
                    <measurement group_id="O2" value="59.3" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-Hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="181"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5" spread="0.76"/>
                    <measurement group_id="O2" value="57.9" spread="0.79"/>
                  </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>Statistical analysis during daytime is reported.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.532</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis during 24-hour period is reported.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.738</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>2.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Severe Hypoglycemia at Week 16</title>
        <description>Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.</description>
        <time_frame>Baseline through Week 16</time_frame>
        <population>All randomized participants with evaluable hypoglycemic data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Severe Hypoglycemia at Week 16</title>
          <description>Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.</description>
          <population>All randomized participants with evaluable hypoglycemic data.</population>
          <units>Events per 100 participant years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
                <count group_id="O2" value="214"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.95"/>
                    <measurement group_id="O2" value="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Documented Symptomatic Hypoglycemia at Week 16</title>
        <description>Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of &lt;54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.</description>
        <time_frame>Baseline through Week 16</time_frame>
        <population>All randomized participants with evaluable hypoglycemic data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Documented Symptomatic Hypoglycemia at Week 16</title>
          <description>Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of &lt;54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.</description>
          <population>All randomized participants with evaluable hypoglycemic data.</population>
          <units>Events per participant per year</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
                <count group_id="O2" value="214"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.7" spread="2.48"/>
                    <measurement group_id="O2" value="24.6" spread="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16</title>
        <description>1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline 1,5-AG data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16</title>
          <description>1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.</description>
          <population>All randomized participants with baseline and at least one post-baseline 1,5-AG data.</population>
          <units>milligram per liter (mg/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.116"/>
                    <measurement group_id="O2" value="0.11" spread="0.121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16</title>
        <description>SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, HbA1c stratum : less than or equal to (≤)7.5%, greater than (&gt;)7.5% and participant's personal CGM or FGM use during the study), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline SMBG data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16</title>
          <description>SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, HbA1c stratum : less than or equal to (≤)7.5%, greater than (&gt;)7.5% and participant's personal CGM or FGM use during the study), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.</description>
          <population>All randomized participants with baseline and at least one post-baseline SMBG data.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Morning Premeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="2.76"/>
                    <measurement group_id="O2" value="0.5" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Morning 1-hour Postmeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="3.15"/>
                    <measurement group_id="O2" value="-12.9" spread="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Morning 2-hour Postmeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                    <count group_id="O2" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="3.04"/>
                    <measurement group_id="O2" value="-2.9" spread="3.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Midday Premeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="2.82"/>
                    <measurement group_id="O2" value="4.9" spread="2.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Midday 1-hour Postmeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="2.85"/>
                    <measurement group_id="O2" value="-6.3" spread="3.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Midday 2-hour Postmeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="3.14"/>
                    <measurement group_id="O2" value="4.4" spread="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evening Premeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="3.28"/>
                    <measurement group_id="O2" value="17.5" spread="3.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evening 1-hour Postmeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="3.21"/>
                    <measurement group_id="O2" value="8.6" spread="3.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evening 2-hour Postmeal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="3.36"/>
                    <measurement group_id="O2" value="12.2" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bedtime</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="6.37"/>
                    <measurement group_id="O2" value="19.0" spread="6.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Insulin Dose at Week 16</title>
        <description>LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline basal insulin dose data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Insulin Dose at Week 16</title>
          <description>LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.</description>
          <population>All randomized participants with baseline and at least one post-baseline basal insulin dose data.</population>
          <units>units per day (U/day)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="199"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Daily Basal Insulin Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.43"/>
                    <measurement group_id="O2" value="-0.1" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daily Bolus Insulin Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="197"/>
                    <count group_id="O2" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.66"/>
                    <measurement group_id="O2" value="-1.0" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Daily Insulin Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.80"/>
                    <measurement group_id="O2" value="-1.1" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16</title>
        <description>The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>All randomized participants with non-missing baseline value and at least one non-missing post-baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16</title>
          <description>The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.</description>
          <population>All randomized participants with non-missing baseline value and at least one non-missing post-baseline value.</population>
          <units>Percentage of bolus/total insulin dose</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.66"/>
                    <measurement group_id="O2" value="-1.3" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HbA1c &lt;7%</title>
        <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
        <time_frame>Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline HbA1c &lt;7% data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to the post-baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HbA1c &lt;7%</title>
          <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
          <population>All randomized participants with baseline and at least one post-baseline HbA1c &lt;7% data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to the post-baseline data.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="207"/>
                <count group_id="O2" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.77"/>
                    <measurement group_id="O2" value="18.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change</title>
        <description>Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated.</description>
        <time_frame>Baseline through Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change</title>
          <description>Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated.</description>
          <population>All randomized participants with baseline and at least one post-baseline value.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="210"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7"/>
                    <measurement group_id="O2" value="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia &gt;300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change</title>
        <description>Percentage of participants with at least 1 event of unexplained hyperglycemia &gt;300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated.</description>
        <time_frame>Baseline through Week 16</time_frame>
        <population>All randomized participants with baseline and at least one post-baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>Insulin Lispro (Humalog)</title>
            <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Ultra-Rapid Lispro</title>
            <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia &gt;300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change</title>
          <description>Percentage of participants with at least 1 event of unexplained hyperglycemia &gt;300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated.</description>
          <population>All randomized participants with baseline and at least one post-baseline value.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
                <count group_id="O2" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4"/>
                    <measurement group_id="O2" value="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 20 Weeks</time_frame>
      <desc>All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.</desc>
      <group_list>
        <group group_id="E1">
          <title>Insulin Lispro (Humalog) Lead-in</title>
          <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
        </group>
        <group group_id="E2">
          <title>Insulin Lispro (Humalog)</title>
          <description>Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
        </group>
        <group group_id="E3">
          <title>Ultra-Rapid Lispro</title>
          <description>Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.1</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="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </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="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Intestinal dilatation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Herpes zoster oticus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Foreign body in respiratory tract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Maternal exposure during pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="261"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="217"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Ketosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </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="471"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.1</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="15" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="90" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="471"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="217"/>
                <counts group_id="E3" events="41" subjects_affected="35" subjects_at_risk="215"/>
              </event>
              <event>
                <sub_title>Infusion site reaction</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="471"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="217"/>
                <counts group_id="E3" events="60" subjects_affected="47" subjects_at_risk="215"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="471"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="217"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="215"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>ClinicalTrials.gov@lilly.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/NCT03830281
org study id: 16315
secondary id: I8B-MC-ITRO
secondary id: 2015-005358-36
nct id: NCT03830281
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)
      when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16
time frame: Baseline, Week 16
description: HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
measure: Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16
time frame: Baseline, Week 16
description: A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
measure: Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16
time frame: Baseline, Week 16
description: A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
measure: Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16
time frame: Week 16
description: Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares).
measure: Rate of Severe Hypoglycemia at Week 16
time frame: Baseline through Week 16
description: Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.
measure: Rate of Documented Symptomatic Hypoglycemia at Week 16
time frame: Baseline through Week 16
description: Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.
measure: Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16
time frame: Baseline, Week 16
description: 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.
measure: Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
time frame: Baseline, Week 16
description: SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, HbA1c stratum : less than or equal to (≤)7.5%, greater than (>)7.5% and participant's personal CGM or FGM use during the study), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.
measure: Change From Baseline in Insulin Dose at Week 16
time frame: Baseline, Week 16
description: LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.
measure: Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16
time frame: Baseline, Week 16
description: The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.
measure: Percentage of Participants With HbA1c <7%
time frame: Week 16
description: Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
measure: Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change
time frame: Baseline through Week 16
description: Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated.
measure: Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change
time frame: Baseline through Week 16
description: Percentage of participants with at least 1 event of unexplained hyperglycemia >300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated.
arm group label: Insulin Lispro (Humalog)
arm group type: Active Comparator
description: Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
arm group label: Ultra-Rapid Lispro
arm group type: Experimental
description: Participants received individual dose of 100 units per milliliter (U/mL) ultra rapid lispro by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
intervention type: Drug
intervention name: Ultra-Rapid Lispro
description: Administered SC
arm group label: Ultra-Rapid Lispro
other name: LY900014
other name: Insulin lispro
intervention type: Drug
intervention name: Insulin Lispro
description: Administered SC
arm group label: Insulin Lispro (Humalog)
other name: Humalog
other name: LY275585
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Australia
country: Austria
country: Canada
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Puerto Rico
country: Spain
country: United States
url: https://www.lillytrialguide.com/en-US/studies/type-1-diabetes/ITRO#?postal=
description: A Study Comparing LY900014 to Insulin Lispro in Adults With Type 1 Diabetes Using Insulin Pump Therapy
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Lispro
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: http://vivli.org/
provided document: 
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