Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338AM1)(COMPLETED)
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: SCH 497079 Drug: Placebo Drug: Metformin extended release |
Phase | Phase 1 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00673465 |
First Received | May 5, 2008 |
Last Updated | October 25, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | May 5, 2008 |
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Last Updated Date | October 25, 2013 |
Start Date | May 2008 |
Estimated Primary Completion Date | December 2008 |
Current Primary Outcome Measures | 24-hour glycemic profile [Time Frame: after 4 weeks of treatment] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338AM1)(COMPLETED) |
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Official Title | A Randomized, Placebo-controlled, Three-Way Crossover Study to Evaluate the Effect of SCH 497079 on Metabolic Parameters and to Determine the Influence of Race/Ethnic Origin on Therapeutic Response |
Brief Summary | The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: SCH 497079 100 mg, administered orally, once-daily x 28 days Drug: Placebo Placebo capsules matching SCH 497079 administered once daily x 28 days Drug: Metformin extended release 1500 mg, administered orally, once-daily x 28 days |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 17 |
Estimated Completion Date | December 2008 |
Estimated Primary Completion Date | December 2008 |
Eligibility Criteria | Inclusion Criteria: - >=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA subjects) - Clinical laboratory tests (CBC blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia) - Type 2 diabetes mellitus Exclusion Criteria: - Female subjects who are premenopausal or are not surgically sterilized. Subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding. - Subjects who have received insulin therapy within 6 months, prior to Day/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00673465 |
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Other Study ID Numbers | P05338 |
Has Data Monitoring Committee | No |
Information Provided By | Merck Sharp & Dohme Corp. |
Study Sponsor | Merck Sharp & Dohme Corp. |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | October 2013 |