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A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dulaglutide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Pediatrics

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening.
  • Have HbA1c >6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5 % to ≤9%.
  • Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).

Exclusion Criteria:

  • Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.
  • A history of, or at risk for pancreatitis.
  • Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening.
  • A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg.
  • Active or treated cancer.
  • A blood disorder where an accurate HbA1c may not be obtainable.
  • A female of childbearing age, sexually active and not on birth control.
  • Pregnant or plan to be pregnant during the study, or breastfeeding.
  • Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).
  • Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.
  • Using prescription weight loss medications in the last 30 days, or plan to use.
  • Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.

Sites / Locations

  • University of Alabama Birmingham
  • University of Arizona
  • Advanced Research Center
  • Division of Endocrinology, Diabetes, and Metabolism
  • Childrens Hospital of Orange County
  • Center of Excellence in Diabetes & Endocrinology
  • Rady Childrens Hospital - San Diego
  • JC Cabaccan
  • Touro University
  • Children's National Medical Center
  • Florida Center for Endocrinology & Metabolism
  • St. Luke's Regional Medical Center
  • University of Illinois at Chicago
  • Indiana University Health Hospital
  • Pennington Biomedical Research Center
  • Children's Mercy Hospital
  • ECU Pediatric Specialty Care
  • Cincinnati Childrens Hospital Medical Center
  • Children's Hospital of Philadelphia
  • Childrens Hospital of Pittsburgh
  • Seattle Children's Hospital Research Foundation
  • Multicare Health System
  • CAMC Institute
  • Centro de Pesquisas em Diabetes
  • Instituto da Criança com Diabetes
  • Instituto Estadual de Diabetes e Endocrinologia
  • Hospital PUC-CAMPINAS
  • CPCLIN
  • Hospital da Clinicas da Faculdade de Medicina da USP
  • Hospital das Clinicas da FMRP
  • UNIFESP - Escola Paulista de Medicina
  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
  • Hopital Robert Debre
  • Praxis Dr. med. Landers
  • Zentrum für klinische Studien
  • RED-Institut GmbH
  • Heim Pal Gyermekkorhaz
  • Sir Ganga Ram Hospital
  • Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre
  • Manipal Hospital
  • M S Ramaiah Medical College Hospital
  • Deenanath Mangeshkar Hospital & Research Centre
  • Post Graduate Institute of Medical Education & Research
  • Banaras Hindu University - BHU
  • Park Clinic
  • Apollo Gleneagles Hospitals Kolkata
  • Health Pharma Professional Research, S.A. de C.V.
  • Centro de Inv. Medica de Occidente, SC
  • Centro Medico San Francisco
  • Cli-nica Hospital Cemain
  • Hospital Angeles Puebla
  • Arke Estudios Clinicos S.A. de C.V.
  • Centro de Diabetes y Endocrinologia Pediatrica de PR
  • King Saud University Hospital
  • King Salman bin Abdulaziz Hospital - Diabetic Center
  • Ankara University Medicine Hospital
  • Sami Ulus Education & Research Hospital
  • Duzce University Medical Faculty
  • Ondokuz Mayis University Medical Faculty
  • Alder Hey Children's Hospital
  • St James's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Placebo/0.75 milligram (mg) Dulaglutide

0.75 mg Dulaglutide

1.5 mg Dulaglutide

Arm Description

Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).

Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.

Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).

Secondary Outcome Measures

Change From Baseline in HbA1c (Individual Doses) at Week 26
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group [ less than (<) 8%, greater than or equal to (>=) 8%).
Percentage of Participants With HbA1c ≤7.0%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Change From Baseline in Body Mass Index (BMI) at Week 26
BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (< 8%, >= 8%).
Percentage of Participants With Self-Reported Events of Hypoglycemia
Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose <54mg/dL.
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.
Number of Participants With Adjudicated Pancreatitis
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Change From Baseline in Pancreatic Enzymes at Week 26
Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.
Number of Participants With Thyroid Treatment-Emergent Adverse Events
Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.
Change From Baseline in Serum Calcitonin at Week 26
Change from Baseline in Serum Calcitonin was evaluated.
Percentage of Participants With Allergic, Hypersensitivity Reactions
The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Percentage of Participants With Injection Site Reactions
The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Number of Participants With Anti-Dulaglutide Antibodies
Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)
PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.
PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]
PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.

Full Information

First Posted
November 10, 2016
Last Updated
June 7, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02963766
Brief Title
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Acronym
AWARD-PEDS
Official Title
A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 1, 2022
Overall Recruitment Status
Completed
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
June 12, 2021 (Actual)
Study Completion Date
January 12, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Pediatrics

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo/0.75 milligram (mg) Dulaglutide
Arm Type
Experimental
Arm Description
Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).
Arm Title
0.75 mg Dulaglutide
Arm Type
Experimental
Arm Description
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.
Arm Title
1.5 mg Dulaglutide
Arm Type
Experimental
Arm Description
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
LY2189265
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26
Description
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Individual Doses) at Week 26
Description
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).
Time Frame
Baseline, Week 26
Title
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
Description
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group [ less than (<) 8%, greater than or equal to (>=) 8%).
Time Frame
Baseline, Week 26
Title
Percentage of Participants With HbA1c ≤7.0%
Description
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Time Frame
Week 26
Title
Change From Baseline in Body Mass Index (BMI) at Week 26
Description
BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (< 8%, >= 8%).
Time Frame
Baseline, Week 26
Title
Percentage of Participants With Self-Reported Events of Hypoglycemia
Description
Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose <54mg/dL.
Time Frame
Week 26
Title
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia
Description
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.
Time Frame
Week 26
Title
Number of Participants With Adjudicated Pancreatitis
Description
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame
Week 26
Title
Change From Baseline in Pancreatic Enzymes at Week 26
Description
Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.
Time Frame
Baseline, Week 26
Title
Number of Participants With Thyroid Treatment-Emergent Adverse Events
Description
Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.
Time Frame
Week 26
Title
Change From Baseline in Serum Calcitonin at Week 26
Description
Change from Baseline in Serum Calcitonin was evaluated.
Time Frame
Baseline, Week 26
Title
Percentage of Participants With Allergic, Hypersensitivity Reactions
Description
The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame
Week 26
Title
Percentage of Participants With Injection Site Reactions
Description
The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame
Week 26
Title
Number of Participants With Anti-Dulaglutide Antibodies
Description
Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Time Frame
Baseline through Week 56
Title
Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)
Description
PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.
Time Frame
Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit
Title
PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]
Description
PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.
Time Frame
Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening. Have HbA1c >6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5 % to ≤9%. Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50 kilograms (110 pounds). Exclusion Criteria: Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome. A history of, or at risk for pancreatitis. Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening. A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg. Active or treated cancer. A blood disorder where an accurate HbA1c may not be obtainable. A female of childbearing age, sexually active and not on birth control. Pregnant or plan to be pregnant during the study, or breastfeeding. Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin). Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day. Using prescription weight loss medications in the last 30 days, or plan to use. Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.
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
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Advanced Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Division of Endocrinology, Diabetes, and Metabolism
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Childrens Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
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
Rady Childrens Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
JC Cabaccan
City
San Jose
State/Province
California
ZIP/Postal Code
95148
Country
United States
Facility Name
Touro University
City
Vallejo
State/Province
California
ZIP/Postal Code
94592
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Center for Endocrinology & Metabolism
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Health Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4124
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
ECU Pediatric Specialty Care
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Childrens Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Seattle Children's Hospital Research Foundation
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Multicare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
CAMC Institute
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
Centro de Pesquisas em Diabetes
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
Instituto da Criança com Diabetes
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Instituto Estadual de Diabetes e Endocrinologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20211-340
Country
Brazil
Facility Name
Hospital PUC-CAMPINAS
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13034-685
Country
Brazil
Facility Name
CPCLIN
City
São Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Hospital da Clinicas da Faculdade de Medicina da USP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Hospital das Clinicas da FMRP
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
UNIFESP - Escola Paulista de Medicina
City
São Paulo
ZIP/Postal Code
04022-001
Country
Brazil
Facility Name
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Praxis Dr. med. Landers
City
Mayen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56727
Country
Germany
Facility Name
Zentrum für klinische Studien
City
Sankt Ingbert
State/Province
Saarland
ZIP/Postal Code
66386
Country
Germany
Facility Name
RED-Institut GmbH
City
Oldenburg in Holstein
State/Province
Schleswig Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Heim Pal Gyermekkorhaz
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380007
Country
India
Facility Name
Manipal Hospital
City
Bangalore
State/Province
Karmnataka
ZIP/Postal Code
560017
Country
India
Facility Name
M S Ramaiah Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Post Graduate Institute of Medical Education & Research
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Banaras Hindu University - BHU
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221005
Country
India
Facility Name
Park Clinic
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700017
Country
India
Facility Name
Apollo Gleneagles Hospitals Kolkata
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Health Pharma Professional Research, S.A. de C.V.
City
Mexico City
State/Province
Federal District
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Centro de Inv. Medica de Occidente, SC
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45116
Country
Mexico
Facility Name
Centro Medico San Francisco
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Cli-nica Hospital Cemain
City
Tampico
State/Province
Tamaulipas
ZIP/Postal Code
89249
Country
Mexico
Facility Name
Hospital Angeles Puebla
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Facility Name
Arke Estudios Clinicos S.A. de C.V.
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Centro de Diabetes y Endocrinologia Pediatrica de PR
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
King Saud University Hospital
City
Riyadh
ZIP/Postal Code
11472
Country
Saudi Arabia
Facility Name
King Salman bin Abdulaziz Hospital - Diabetic Center
City
Riyadh
ZIP/Postal Code
12769
Country
Saudi Arabia
Facility Name
Ankara University Medicine Hospital
City
Ankara
State/Province
Mamak
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Sami Ulus Education & Research Hospital
City
Ankara
ZIP/Postal Code
06080
Country
Turkey
Facility Name
Duzce University Medical Faculty
City
Duzce
ZIP/Postal Code
81620
Country
Turkey
Facility Name
Ondokuz Mayis University Medical Faculty
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Alder Hey Children's Hospital
City
Liverpool
State/Province
Lancashire
ZIP/Postal Code
L14 5AB
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

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
https://www.vivli.org/
Citations:
PubMed Identifier
35658022
Citation
Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Perez M, Bismuth E, Dib S, Cho JI, Cox D; AWARD-PEDS Investigators. Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. N Engl J Med. 2022 Aug 4;387(5):433-443. doi: 10.1056/NEJMoa2204601. Epub 2022 Jun 4.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/5RwyJT8t9uI0ISG4U4SEu0
Description
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)

Learn more about this trial

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

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