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Tracking Information | |||||
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First Received Date ICMJE | February 21, 2008 | ||||
Last Updated Date | January 14, 2012 | ||||
Start Date ICMJE | February 2008 | ||||
Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
The effect of treatment of MK0893 in combination with sitagliptin or with metformin compared to the combination of sitagliptin and metformin on 24-hour weighted mean glucose levels after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00631488 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
To assess the safety and tolerability of MK0893 after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: Yes ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)(COMPLETED) | ||||
Official Title ICMJE | A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control | ||||
Brief Summary | This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | |||||
* 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 | ||||
Enrollment ICMJE | 146 | ||||
Completion Date | January 2009 | ||||
Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00631488 | ||||
Other Study ID Numbers ICMJE | MK-0893-015, 2007_646 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Merck | ||||
Study Sponsor ICMJE | Merck | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Merck | ||||
Verification Date | January 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |