Type 2 Diabetes Treatment with Dulaglutide – Phase III

Extension Study 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 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’ hemoglobin A1c and fasting blood glucose levels, 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

The study is divided into four periods. The first period takes about a month and is for screening to determine if participants are eligible. In the second period, participants will take either the study drug or a placebo in pill form once a week for 26 weeks. Random selection determines whether the participant receives the drug or a placebo. In the third period, all participants take the study drug for 26 weeks, and the fourth period is the month after the medication is stopped. Clinic visits for exams, blood samples and other tests occur at specific intervals and one month after participants stop taking dulaglutide.
Visits: 17
Duration: 14 months

Status: Open 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