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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-17
SponsorEli Lilly and Company

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dulaglutide

Treatment groups

55 Participants
are divided into 1 treatment group

Sponsors and collaborators