Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

Brief summary:
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.

Detailed description:

Arms:
arm 1: Participants were randomized to sitagliptin 50 mg arm 2: Participants were randomized to sitagliptin 100 mg arm 3: Participants were randomized to a single dose of sitagliptin 200 mg arm 4: Participants were randomized to matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg

Interventions: intervention 1: Sitagliptin phosphate intervention 2: Comparator: matching placebo
Intervention descriptions: intervention 1: Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg. intervention 2: Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.

Protocol document: