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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.
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
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.
Duration: 14 months
Eli Lilly and Company
Study Description at National Institutes of Health
Endocrinology, Diabetes and Metabolism Research
Center for Pediatric Research in Obesity and Metabolism
Silva Arslanian, MD
For more information about the study or enrollment, please contact:
Dulaglutide study coordinator Nancy Guerra, CRNP
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UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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