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 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