DRUG
Dulaglutide
Administered SC
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Status
Recruiting
Phase
Phase 3
Enrollment
55
Locations
51
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 18, 2024
Study start
Jan 10, 2025
Primary completion
Dec 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Jul 20, 2026
Outcomes
What the study measures.
Primary outcomes
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Time frame · Baseline through Week 26
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide
Time frame · Predose through Week 30
PK: Maximum Observed Concentration (Cmax) of Dulaglutide
Time frame · Predose through Week 30
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 26
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 26
Change from Baseline in Total Cholesterol
Time frame · Baseline, Week 26
Change from Baseline in the EQ-5D-Y-5L
Time frame · Baseline, Week 26
Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)
Time frame · Baseline, Week 26
Eligibility
Who can take part.
- Minimum age
- 10 Years
- Maximum age
- 17 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening. * Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile Exclusion Criteria: * Have Type 1 diabetes * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening * After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome * Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening
Study locations
51 registered sites.
Argentina · Mexico · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Arizona
Tucson, Arizona, United States
Arkansas Childrens Hospital
Little Rock, Arkansas, United States
Division of Endocrinology, Diabetes, and Metabolism
Los Angeles, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's Hospital of Colorado
Denver, Colorado, United States
Yale Diabetes Research
New Haven, Connecticut, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Nemours Children's Health
Jacksonville, Florida, United States
D&H National Research Centers, Inc
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
D&H Tamarac Research Center, LLC
Tamarac, Florida, United States
University of South Florida
Tampa, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
Centricity Research Columbus Endocrinology
Columbus, Georgia, United States
St. Luke's Children's Endocrinology and Diabetes
Boise, Idaho, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Center for Diabetes and Metabolic Diseases Indiana University
Indianapolis, Indiana, United States
University of Iowa Stead Family Children's Hospitals
Iowa City, Iowa, United States
Norton Children's Endocrinology
Louisville, Kentucky, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Dulaglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
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Not applicable
Completed
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2026-07
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
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Not applicable
Completed
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2026-07
Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
Brigham and Women's Hospital · Type 2 Diabetes Mellitus · Obesity
Not applicable
Completed
120,000
2026-07
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
Eli Lilly · Type 2 Diabetes Mellitus
Phase 3
Completed
13,299
2026-07
Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus
ProGen. Co., Ltd. · Type 2 Diabetes
Phase 2
Not yet recruiting
60
2026-07
Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus
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Phase 1 / Phase 2
Enrolling by invitation
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.