Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: no

Brief summary:
This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: Co-administration of sitagliptin and metformin arm 4: Co-administration of placebo to sitagliptin and placebo to metformin

Interventions: intervention 1: sitagliptin phosphate intervention 2: metformin hydrochloride intervention 3: Comparator: placebo sitagliptin intervention 4: Comparator: placebo metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods. intervention 2: Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods. intervention 3: Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods. intervention 4: Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.

Protocol document: