A Study of the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus (MK-3577-009)(TERMINATED)
Overview[ - collapse ][ - ]
Purpose | This study will assess the safety and efficacy of MK3577 when given in the morning, the evening, or twice a day as compared to placebo and to metformin. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Comparator: Placebo to MK3577 Drug: MK3577 Drug: Comparator: metformin Drug: MK3577 Drug: MK3577 |
Phase | Phase 2 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00868790 |
First Received | March 24, 2009 |
Last Updated | June 7, 2012 |
Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | March 24, 2009 |
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Last Updated Date | June 7, 2012 |
Start Date | March 2009 |
Estimated Primary Completion Date | July 2010 |
Current Primary Outcome Measures | 24-hour weighted mean glucose-lowering efficacy of MK3577 compared to placebo [Time Frame: 4 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Fasting glucose levels after evening administration of MK3577 or placebo [Time Frame: 4 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | A Study of the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus (MK-3577-009)(TERMINATED) |
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Official Title | A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
Brief Summary | This study will assess the safety and efficacy of MK3577 when given in the morning, the evening, or twice a day as compared to placebo and to metformin. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Comparator: Placebo to MK3577 Placebo to MK3577 tablets twice daily for 4 weeks Drug: MK3577 MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks. Other Names: MK3577Drug: Comparator: metformin Metformin tablets 1000 mg twice daily for 4 weeks. Drug: MK3577 MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks. Other Names: MK3577Drug: MK3577 MK3577 tablets totaling 25 mg twice daily for 4 weeks. Other Names: MK3577 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 118 |
Estimated Completion Date | July 2010 |
Estimated Primary Completion Date | July 2010 |
Eligibility Criteria | Inclusion Criteria: - Patient has type 2 diabetes - Patient is either not taking antihyperglycemic medications for the last 10 weeks OR is taking a single oral antihyperglycemic medication (but not a PPARg agonist) OR is taking a low-dose combination oral antihyperglycemic medication (not a PPARg agonist) at dose less than or equal to 50% of the maximum dose - Female patient is unable to have children Exclusion Criteria: - Patient has a history of type 1 diabetes or ketoacidosis - Patient has been treated with a PPARg agonist in the last 12 weeks - Patient has been treated with insulin in the last 12 weeks - Patient has had prescription lipid-modifying drug therapy in the last 12 weeks - Patient is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication in the last 8 weeks - Patient has a history of coronary artery disease - Patient has had a stroke or transient ischemic attack - Patient has congestive heart failure - Patient is HIV positive - Patient has a history of cancer except certain skin or cervical cancers - Patient is not willing to abstain from alcohol for 48 hours prior to each clinic visit - Patient is breast-feeding - Patient will donate eggs during the study |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00868790 |
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Other Study ID Numbers | 2009_564 |
Has Data Monitoring Committee | Yes |
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 | June 2012 |