Offered by: Nemours Children's Specialty Care, Jacksonville
Location: Jacksonville, Fla.
Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Sitagliptin in Type 2 Diabetes
What is the trial about?
This study is to learn if an anti-diabetes drug called sitagliptin is safe and tolerable in children 10–17 years old. This study will compare the effect of treatment with sitagliptin vs. placebo on A1c levels.
Who can participate?
Participants must be between the ages of 10 and 17 years and have the diagnosis of Type 2 Diabetes. Other inclusion criteria include a body mass index of greater than the 85th percentile and a hemoglobin A1C between 6.5 and 10.0 percent.
What is involved?
The study will last 54 weeks. Study subjects will visit the study doctor about 10 times. The treatment portion of the study is divided into 2 phases. Phase A, will last 20 weeks and Phase B, will last 34 weeks.
In order to monitor for drug safety and efficacy, subjects will have their blood drawn a total of nine times, three 12 lead EKGs will be performed, and bone ages X-ray of the hand will be obtained at randomization, week 20 and week 54 (unless subjects have reached full skeletal maturity).
Contact Nemours Clinical Trials
Trial Name: Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Sitagliptin in Type 2 Diabetes