A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus
Eli Lilly and Company
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.
Eligibility
- Age range
- 10–17 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…
Interventions
- DrugDulaglutide
Administered SC
Locations (51)
- University of ArizonaTucson, Arizona
- Arkansas Childrens HospitalLittle Rock, Arkansas
- Division of Endocrinology, Diabetes, and MetabolismLos Angeles, California
- UCLA Mattel Children's HospitalLos Angeles, California
- University of California, San FranciscoSan Francisco, California
- Children's Hospital of ColoradoDenver, Colorado