Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
NCT ID: NCT01405911
Last Updated: 2020-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
242 participants
INTERVENTIONAL
2011-08-16
2012-04-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
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.
Placebo for Sitagliptin 25 mg
1 tablet orally once daily before breakfast for 8 weeks
Placebo for Sitagliptin 50 mg
1 tablet orally once daily before breakfast for 8 weeks
Sitagliptin 25 mg
Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
Placebo for Sitagliptin 50 mg
1 tablet orally once daily before breakfast for 8 weeks
Sitagliptin 25 mg
1 tablet orally once daily before breakfast for 8 weeks
Sitagliptin 50 mg
Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.
Placebo for Sitagliptin 25 mg
1 tablet orally once daily before breakfast for 8 weeks
Sitagliptin 50 mg
1 tablet orally once daily before breakfast for 8 weeks
Interventions
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Placebo for Sitagliptin 25 mg
1 tablet orally once daily before breakfast for 8 weeks
Placebo for Sitagliptin 50 mg
1 tablet orally once daily before breakfast for 8 weeks
Sitagliptin 25 mg
1 tablet orally once daily before breakfast for 8 weeks
Sitagliptin 50 mg
1 tablet orally once daily before breakfast for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Disease or condition of clear or likely glucose tolerance disorder
* Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug
20 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Kaku K, Kadowaki T, Terauchi Y, Okamoto T, Sato A, Okuyama K, Arjona Ferreira JC, Goldstein BJ. Sitagliptin improves glycaemic excursion after a meal or after an oral glucose load in Japanese subjects with impaired glucose tolerance. Diabetes Obes Metab. 2015 Nov;17(11):1033-41. doi: 10.1111/dom.12507. Epub 2015 Jul 17.
Other Identifiers
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MK-0431-105
Identifier Type: OTHER
Identifier Source: secondary_id
0431-105
Identifier Type: -
Identifier Source: org_study_id
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