Status:
COMPLETED
Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Glucose Intolerance
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 inade...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2012
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT01405911
Start Date
August 16 2011
End Date
April 9 2012
Last Update
January 18 2020
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