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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)

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Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
10 Years
Maximum Age
17 Years

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
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Study Stats
Protocol No.
24-6292
Category
Endocrine and Metabolic Disorders
Pediatric Disorders
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06739122
For detailed technical eligibility, visit ClinicalTrials.gov.