Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: MK-0941 Drug: Comparator: Placebo Biological: Lantus Drug: Metformin |
Phase | Phase 2 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00767000 |
First Received | October 3, 2008 |
Last Updated | February 27, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | October 3, 2008 |
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Last Updated Date | February 27, 2014 |
Start Date | October 2008 |
Estimated Primary Completion Date | June 2010 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED) |
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Official Title | A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin |
Brief Summary | The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy. |
Detailed Description | This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: MK-0941 MK-0941 tablets three times daily Drug: Comparator: Placebo Matching placebo to MK-0941 three times daily Biological: Lantus Lantus injection once daily Other Names: Insulin glargine injectionDrug: Metformin Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 813 |
Estimated Completion Date | June 2010 |
Estimated Primary Completion Date | April 2010 |
Eligibility Criteria | Inclusion Criteria: - has type 2 diabetes mellitus - has body mass index >20 and <43 kg/m^2 - is a male, or a female who is unlikely to conceive - currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus Extension Study Inclusion Criteria: - completed the base study either on double-blind study medication or as part of the post-treatment follow up population - had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period Exclusion Criteria: - has any history of Type 1 diabetes mellitus or ketoacidosis - has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks - has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness - is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1 - has undergone surgery within 30 days prior to Visit 1 or has planned major surgery |
Gender | Both |
Ages | 21 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00767000 |
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Other Study ID Numbers | 0941-007 |
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 | February 2014 |