A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
- Registration Number
- NCT06739122
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
- 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
- Have Type 1 diabetes
- Have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dulaglutide Dulaglutide Participants will receive dulaglutide subcutaneously (SC)
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration 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 Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide Predose through Week 30 PK: Maximum Observed Concentration (Cmax) of Dulaglutide Predose through Week 30 Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 26 Percent Change from Baseline in Body Weight Baseline, Week 26 Change from Baseline in Total Cholesterol Baseline, Week 26 Change from Baseline in the EQ-5D-Y-5L Baseline, Week 26 Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B) Baseline, Week 26
Related Research Topics
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Trial Locations
- Locations (30)
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 Fransciso, California, United States
Yale Diabetes Research
🇺🇸New Haven, Connecticut, United States
Emerson Clinical Research Institute
🇺🇸Washington, District of Columbia, United States
Children's National Medical Center
🇺🇸Washington, 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
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
Norton Children's Endocrinology
🇺🇸Louisville, Kentucky, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of New Mexico Hospital
🇺🇸Albuquerque, New Mexico, United States
WBMD Pediatrics
🇺🇸Buffalo, New York, United States
Cohen Children's Medical Center Division of Pediatric Endocrinology
🇺🇸Hyde Park, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
UNC Children's Hospital
🇺🇸Chapel Hill, North Carolina, United States
Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Childrens Outpatient Center
🇺🇸Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Prisma Health Pediatric Endocrinology
🇺🇸Columbia, South Carolina, United States
Texas Childrens Hospital
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States