A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00631488
First received: February 21, 2008
Last updated: January 14, 2012
Last verified: January 2012
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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 | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 | Not Provided | ||||
| 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 Arm (s) |
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| Publications * | Not Provided | ||||
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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 | ||||
| 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 | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00631488 | ||||
| Other Study ID Numbers ICMJE | MK-0893-015, 2007_646 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Merck | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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