Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

• Status: Completed
• Trial end date: 2012-04-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Impaired glucose tolerance

• On diet/exercise therapy

• Unlikely to conceive

• Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

Exclusion Criteria:

• History of diabetes mellitus

• Disease or condition of clear or likely glucose tolerance disorder

• Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug