Type 2 Diabetes Treatment with Dulaglutide – Phase III

Randomized Double-Blind Study with an Open Label Extension Comparing the Effect of Once-weekly Dulaglutide with Placebo in Pediatric Patients with Type 2 Diabetes Mellitus

Protocol Description

The purpose of this study is to test the safety and efficacy of the investigational drug dulaglutide when used by pediatric patients with type 2 diabetes. Dulaglutide will be tested at one of two dosage levels and researchers will be monitoring for changes in participants’ diabetes control, including hemoglobin A1c, fasting blood glucose levels, and changes in weight, among other outcome measures.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants of both genders, ages 10 through 17, who have type 2 diabetes and are being treated with a diet and exercise program and who may be taking metformin or long-acting insulin.
Males and Females: Ages 10 through 17

Requirements

Two doses of dulaglutide via subcutaneous injection (0.75 mg/week and 1.5 mg/week) and placebo will be used in the 26-week double-blind period of the trial. Following this, during the 26-week open-label extension, patients who received dulaglutide will remain on the same dose they received in the double-blind period, while patients on placebo during the double-blind period will receive dulaglutide 0.75 mg/week. After completion of the open-label extension, patients will return 4 weeks later for safety follow-up.
Visits: 17
Duration: 14 months

Status: Closed to Enrollment

Source(s) of Support

Eli Lilly and Company

Primary Investigator

Silva Arslanian, MD

Contact Information

For more information about the study or enrollment, please contact:
Dulaglutide study coordinator Nancy Guerra, CRNP
412-692-8405