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
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 55
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
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Exclusion Criteria
- Have Type 1 diabetes
- Have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin within 90 days 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 90 days prior to screening
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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
Trial Locations
- Locations (1)
D&H Tamarac Research Center, LLC
🇺🇸Tamarac, Florida, United States