Testing New Dulaglutide Doses 3.0 mg and 4.5 mg in Children and Teens Aged 10 to 17 With Type 2 Diabetes

What this Trial Is About

Researchers are studying dulaglutide, a medication given by injection under the skin, to explore new dosing options for children and teenagers aged 10 to under 18 years with Type 2 Diabetes. This phase 3 trial focuses on evaluating the safety of dulaglutide doses 3.0 mg and 4.5 mg in pediatric participants who have Type 2 Diabetes managed with diet, exercise, and stable doses of metformin andor basal insulin. The study is sponsored by Eli Lilly and Company and aims to better understand how dulaglutide works in this younger population. Participants will receive dulaglutide subcutaneously, with no placebo group as this is a single-group study. The study treatment will be administered over a period of about eight months. Throughout the study, researchers will closely monitor the number of serious side effects that might be related to the drug. Additional evaluations will include measuring dulaglutide levels in the blood over time, changes in blood sugar control Hemoglobin A1c, body weight, cholesterol levels, quality of life assessments, and beta cell function. During the study, participants will attend visits where blood samples and other health assessments will be performed at specific times including baseline, week 26, and week 30. Researchers will use these assessments to track the medications impact and monitor for safety. Participation involves regular monitoring over approximately eight months, allowing researchers to collect important data on how dulaglutide affects young people living with Type 2 Diabetes.

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