Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes

Clinical Trial

Offered by: Nemours Children's Health, Jacksonville
Location: Jacksonville, Fla.

Trial Name

Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes

What is the trial about?

The purpose of this research study is to learn about the safety and effectiveness of an investigational drug, Alogliptin 25mg QD compared to a placebo when taken alone, or when added onto a background of metformin alone, insulin alone, or a combination of metformin and insulin, as measured by the change in A1C.

Who can participate?

Children between the ages of 10-17 years old and have type 2 diabetes mellitus.

What is involved?

This study will last for about 54 weeks, but could last longer. This will include a screening period of up to 14 days, followed by a stabilization period if the study doctor decides it is needed. The length of participation in the Pre-Randomization Stabilization period will vary for each subject based on his/her status. The treatment period, which is when you/your child will have to take the study medication, will last for about 52 weeks. After that, you will have one follow-up visit.

In this study, your child will have an equal 50% (1 in 2) chance of being assigned to either Alogliptin or placebo.  Whichever group you child is assigned, if they are taking metformin or insulin for their diabetes, they will be required to maintain their current therapy at the same dose throughout the first 26 weeks of the double-blind treatment period. There will be no dietary restrictions and no restrictions on normal daily physical activities during the participation in this study. Subjects will be instructed on proper nutrition and exercise, how to recognize signs and symptoms of hypoglycemia, and the use of a glucometer. There will be at least six blood draws, but there could be more depending on the need for the stabilization period.  There will also be four ECGs throughout the study.