MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00482729 |
Recruitment Status :
Completed
First Posted : June 5, 2007
Results First Posted : March 15, 2010
Last Update Posted : June 9, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Tracking Information | |||||
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First Submitted Date ICMJE | May 31, 2007 | ||||
First Posted Date ICMJE | June 5, 2007 | ||||
Results First Submitted Date ICMJE | December 9, 2009 | ||||
Results First Posted Date ICMJE | March 15, 2010 | ||||
Last Update Posted Date | June 9, 2017 | ||||
Actual Study Start Date ICMJE | June 19, 2007 | ||||
Actual Primary Completion Date | November 3, 2008 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change From Baseline in Hemoglobin A1c (A1C) at Week 18 [ Time Frame: Baseline and Week 18 ] A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
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Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED) | ||||
Official Title ICMJE | 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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Type 2 Diabetes Mellitus | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
1246 | ||||
Original Enrollment ICMJE | Not Provided | ||||
Actual Study Completion Date ICMJE | April 27, 2009 | ||||
Actual Primary Completion Date | November 3, 2008 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 78 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | Puerto Rico, United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00482729 | ||||
Other Study ID Numbers ICMJE | 0431A-079 MK0431A-079 2007_548 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Merck Sharp & Dohme Corp. | ||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | ||||
Verification Date | May 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |