MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: metformin |
Phase | Phase 3 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00482729 |
First Received | May 31, 2007 |
Last Updated | November 12, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | May 31, 2007 |
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Last Updated Date | November 12, 2013 |
Start Date | June 2007 |
Estimated Primary Completion Date | April 2009 |
Current Primary Outcome Measures | Change From Baseline in Hemoglobin A1c (A1C) at Week 18 [Time Frame: Baseline and Week 18] [Designated as safety issue: No]A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED) |
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Official Title | A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) |
Brief Summary | The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: sitagliptin phosphate (+) metformin hydrochloride sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period. Other Names:
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period Other Names: metformin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 1246 |
Estimated Completion Date | April 2009 |
Estimated Primary Completion Date | November 2008 |
Eligibility Criteria | Inclusion Criteria: - Patient has type 2 diabetes mellitus - Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent - Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy - Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months - Patient is a male, or a female who is unlikely to conceive Exclusion Criteria: - Patient has type 1 diabetes mellitus or history of ketoacidosis |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00482729 |
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Other Study ID Numbers | 0431A-079 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Merck Sharp & Dohme Corp. |
Study Sponsor | Merck Sharp & Dohme Corp. |
Collaborators | Not Provided |
Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
Verification Date | November 2013 |