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

Purpose

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.

Condition

  • Type 2 Diabetes

Eligibility

Eligible Ages
Between 10 Years and 17 Years
Eligible Sex
All
Accepts 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 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dulaglutide 		Participants will receive dulaglutide subcutaneously (SC)
  • Drug: Dulaglutide
    Administered SC
    Other names:
    • LY2189265

Recruiting Locations

UT Health Houston
Houston, Texas 77030
Contact:
713-500-7257

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com