A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06739122

27198

H9X-MC-GBGS (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

55 participants in 1 patient group

Dulaglutide

Experimental group

Description:

Participants will receive dulaglutide subcutaneously (SC)

Treatment:

Drug: Dulaglutide