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

NCT06739122

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Type 2 Diabetes

Interventions: Dulaglutide

Countries: United States, Argentina, Mexico

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 overview

Sex: ALL

Age: 10 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (51)

Tucson, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Jackson, Mississippi, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
Hyde Park, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
+ 21 more on CT.gov