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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)

Eli Lilly and Company
ClinicalTrials.gov ยท December 18, 2024
Plain-language summary

Registered Phase 3 interventional trial (recruiting). 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.

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Trial record

Registered clinical trial record on ClinicalTrials.gov (NCT06739122). This describes a planned, ongoing, or completed study โ€” it is NOT peer-reviewed results. Status: recruiting. Study type: interventional. Phase: Phase 3. Sponsor: Eli Lilly and Company. Conditions: Type 2 Diabetes. Interventions: Dulaglutide. 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 outcome measures: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration. Eligibility: 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 โ‰ฅ50 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 โ‰ฅ1 episode of severe hypoglycemia and/or โ‰ฅ1 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

This is a registered clinical-trial record from ClinicalTrials.gov โ€” a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.

Educational summary of published research โ€” not medical advice. License: public-domain. Full text is shown only where licensing permits.