With the rise of type 2 diabetes (T2DM) amongst pediatric patients, it is imperative to expand safe and effective treatment options. We are currently participating as investigators for a Phase III sitagliptin research study for pediatric patients with T2DM who are not well-controlled on metformin monotherapy. As an investigator, we would like to ask for your help with patient referrals.
Sitagliptin, an investigational, oral medication, is being assessed for pediatric patients (10 – 17 years of age, inclusive) with T2DM who are inadequately controlled on metformin monotherapy. Sitagliptin – combined with metformin – will be compared to metformin monotherapy over a 20-week treatment period. All investigational medications, monitoring, and study-related care – including diet and exercise counseling and monitoring – will be provided at no cost.
- Patient age is 10 – 17 years old (inclusive)
- Patient diagnosed with T2DM based on ADA criteria
- BMI >85th percentile
- No insulin for at least 6 months
- A1C > 7.0% and ≤ 10.0% on current metformin regimen (> 1500 mg/day for > 12 weeks)