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A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy (PRONTO-Pump-2)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ultra-Rapid Lispro
Insulin Lispro
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have been diagnosed with T1D and continuously using insulin for at least 1 year
  • Have been using CSII therapy for a minimum of 6 months
  • Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
  • Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days

Exclusion Criteria:

  • Have hypoglycemia unawareness
  • Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
  • Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening

Sites / Locations

  • John Muir Physician Network Clinical Research Center
  • Valley Research
  • Marin Endocrine Associates
  • Diabetes and Endocrine Associates
  • First Valley Medical Group
  • Center of Excellence in Diabetes & Endocrinology
  • University Clinical Investigators, Inc.
  • Coastal Metabolic Research Centre
  • Barbara Davis Center for Childhood Diabetes
  • ALL Medical Research, LLC
  • Sun Coast Clinical Research, Inc
  • Metabolic Research Institute Inc.
  • Atlanta Diabetes Associates
  • Endocrine Research Solutions, Inc.
  • East West Medical Institute
  • Rocky Mountain Diabetes and Osteoporosis Center
  • Northwestern Feinberg School of Medicine
  • Prairie Education and Research Cooperative
  • Iderc, P.L.C.
  • Kentucky Diabetes Endocrinology Center
  • Endocrine and Metabolic Consultants
  • Palm Research Center
  • Palm Research Center
  • Southern New Hampshire Diabetes and Endocrinology
  • Physicians East
  • Thomas Jefferson University
  • Texas Diabetes and Endocrinology-Austin South
  • Dallas Diabetes Endocrine Center
  • Texas Diabetes and Endocrinology, P.A.
  • Private: Dr. Larry Stonesifer
  • Rainier Clinical Research Center
  • Tacoma Center for Arthritis Research, PS
  • The AIM Centre
  • GP Plus Marion
  • Box Hill Hospital
  • Barwon Health - The Geelong Hospital
  • Fremantle Hospital
  • Universitätsklinikum Graz
  • VIVIT Institut am LKH Feldkirch
  • Universitätsklinikum Salzburg
  • KA Rudolfstiftung
  • LMC Endocrinology Centres Ltd.
  • LMC Endocrinology Centres Ltd.
  • LMC Endocrinology Centres
  • LMC Endocrinology Centres Ltd.
  • IRCM
  • LMC Endocrinology Centres Ltd.
  • CHU Toulouse Hopital de Rangueil
  • Clinique Hotel Dieu
  • Centre hospitalier universitaire Lapeyronie
  • Hopital Cochin
  • Hôpital de HautePierre
  • Groupe hospitalier mutualiste Les Portes du sud
  • Arztpraxis Dr. Cornelia Marck
  • Institut für Diabetesforschung Münster GmbH
  • Praxis Dr. Kempe - Dr. Stemler
  • Schwerpunktpraxis Diabetes
  • RED-Institut GmbH
  • Diabetespraxis Prenzlauer Allee
  • Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
  • Gemeinschaftspraxis für innere Medizin und Diabetologie
  • Budai Irgalmasrendi Korhaz
  • ClinDiab Kft.
  • UNO Medical Trials Kft.
  • TRANTOR 99 Bt.
  • Soroka Medical Center - Pediatric Outpatient Clinic
  • Rambam Health Care Campus
  • Hadassah Medical Center
  • Schneider Medical Center
  • Sheba Medical Center
  • Azienda Ospedaliera Papa Giovanni XXIII
  • IRCCS Ospedale San Raffaele
  • Ospedale San Giovanni di Dio
  • Ospedale Santa Maria delle Croci
  • Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
  • Advanced Clinical Research, LLC
  • Centro de Endocrinologia Alcantara Gonzalez
  • Corporació Sanitaria Parc Tauli
  • Hospital Universitari Arnau de Vilanova
  • Hospital Clinic I Provincial
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen Macarena
  • Hospital Clínico Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Insulin Lispro (Humalog)

Ultra-Rapid Lispro

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16
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.

Secondary Outcome Measures

Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16
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.
Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16
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.
Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16
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).
Rate of Severe Hypoglycemia at Week 16
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.
Rate of Documented Symptomatic Hypoglycemia at Week 16
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.
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16
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.
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
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.
Change From Baseline in Insulin Dose at Week 16
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.
Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16
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.
Percentage of Participants With HbA1c <7%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change
Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated.
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
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.

Full Information

First Posted
February 4, 2019
Last Updated
January 4, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03830281
Brief Title
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Acronym
PRONTO-Pump-2
Official Title
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
January 6, 2020 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Lispro (Humalog)
Arm Type
Active Comparator
Arm 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 Title
Ultra-Rapid Lispro
Arm Type
Experimental
Arm 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(s)
Ultra-Rapid Lispro
Other Intervention Name(s)
LY900014, Insulin lispro
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
Humalog, LY275585
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at 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.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at 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.
Time Frame
Baseline, Week 16
Title
Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at 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.
Time Frame
Baseline, Week 16
Title
Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at 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).
Time Frame
Week 16
Title
Rate of Severe Hypoglycemia at 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.
Time Frame
Baseline through Week 16
Title
Rate of Documented Symptomatic Hypoglycemia at 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.
Time Frame
Baseline through Week 16
Title
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at 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.
Time Frame
Baseline, Week 16
Title
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at 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.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Insulin Dose at 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.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Bolus/Total Insulin Dose Ratio at 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.
Time Frame
Baseline, Week 16
Title
Percentage of Participants With HbA1c <7%
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.
Time Frame
Week 16
Title
Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change
Description
Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated.
Time Frame
Baseline through Week 16
Title
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
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.
Time Frame
Baseline through Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been diagnosed with T1D and continuously using insulin for at least 1 year Have been using CSII therapy for a minimum of 6 months Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days Exclusion Criteria: Have hypoglycemia unawareness Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
John Muir Physician Network Clinical Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Marin Endocrine Associates
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Diabetes and Endocrine Associates
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
First Valley Medical Group
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Center of Excellence in Diabetes & Endocrinology
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Coastal Metabolic Research Centre
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
ALL Medical Research, LLC
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Sun Coast Clinical Research, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Metabolic Research Institute Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
East West Medical Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Northwestern Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
Country
United States
Facility Name
Iderc, P.L.C.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Kentucky Diabetes Endocrinology Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Endocrine and Metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Southern New Hampshire Diabetes and Endocrinology
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Physicians East
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27843
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Texas Diabetes and Endocrinology-Austin South
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Dallas Diabetes Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Diabetes and Endocrinology, P.A.
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Private: Dr. Larry Stonesifer
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Tacoma Center for Arthritis Research, PS
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
The AIM Centre
City
Merewether
State/Province
New South Wales
ZIP/Postal Code
2291
Country
Australia
Facility Name
GP Plus Marion
City
Oaklands Park
State/Province
South Australia
ZIP/Postal Code
5046
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Barwon Health - The Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Universitätsklinikum Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
VIVIT Institut am LKH Feldkirch
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
6800
Country
Austria
Facility Name
Universitätsklinikum Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
KA Rudolfstiftung
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Facility Name
LMC Endocrinology Centres Ltd.
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4N 7L3
Country
Canada
Facility Name
LMC Endocrinology Centres Ltd.
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
LMC Endocrinology Centres
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 4H8
Country
Canada
Facility Name
LMC Endocrinology Centres Ltd.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
IRCM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
LMC Endocrinology Centres Ltd.
City
Ville St-Laurent
State/Province
Quebec
ZIP/Postal Code
H4T 1Z9
Country
Canada
Facility Name
CHU Toulouse Hopital de Rangueil
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Clinique Hotel Dieu
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Centre hospitalier universitaire Lapeyronie
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Cochin
City
Paris CEDEX 14
ZIP/Postal Code
75679
Country
France
Facility Name
Hôpital de HautePierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Groupe hospitalier mutualiste Les Portes du sud
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Arztpraxis Dr. Cornelia Marck
City
Pohlheim
State/Province
Hessen
ZIP/Postal Code
35415
Country
Germany
Facility Name
Institut für Diabetesforschung Münster GmbH
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
Facility Name
Praxis Dr. Kempe - Dr. Stemler
City
Ludwigshafen am Rhein
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67059
Country
Germany
Facility Name
Schwerpunktpraxis Diabetes
City
Saint Ingbert-Oberwürzbach
State/Province
Saarland
ZIP/Postal Code
66386
Country
Germany
Facility Name
RED-Institut GmbH
City
Oldenburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Diabetespraxis Prenzlauer Allee
City
Berlin
ZIP/Postal Code
10409
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
Facility Name
Gemeinschaftspraxis für innere Medizin und Diabetologie
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
ClinDiab Kft.
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
UNO Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
TRANTOR 99 Bt.
City
Budapest
ZIP/Postal Code
1213
Country
Hungary
Facility Name
Soroka Medical Center - Pediatric Outpatient Clinic
City
Beer-Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Schneider Medical Center
City
Petah Tiqva
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale San Giovanni di Dio
City
Olbia
ZIP/Postal Code
07026
Country
Italy
Facility Name
Ospedale Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Advanced Clinical Research, LLC
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Centro de Endocrinologia Alcantara Gonzalez
City
Lomas Verdes
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Corporació Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
State/Province
Cataluña
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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 Sharing 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 Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
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

Learn more about this trial

A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy

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