Conditions: Glucose Intolerance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 242
Healthy volunteers: no

Brief summary:
This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

Detailed description:

Arms:
arm 1: Participants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks. arm 2: Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks. arm 3: Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.

Interventions: intervention 1: Placebo for Sitagliptin 25 mg intervention 2: Placebo for Sitagliptin 50 mg intervention 3: Sitagliptin 25 mg intervention 4: Sitagliptin 50 mg
Intervention descriptions: intervention 1: 1 tablet orally once daily before breakfast for 8 weeks intervention 2: 1 tablet orally once daily before breakfast for 8 weeks intervention 3: 1 tablet orally once daily before breakfast for 8 weeks intervention 4: 1 tablet orally once daily before breakfast for 8 weeks

Protocol document: