Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)(COMPLETED)
Overview[ - collapse ][ - ]
| Purpose | The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: MK0767 Drug: Comparator: placebo (unspecified) Drug: Comparator: metformin |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00543361 |
| First Received | October 5, 2007 |
| Last Updated | February 18, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 5, 2007 |
|---|---|
| Last Updated Date | February 18, 2014 |
| Start Date | May 2003 |
| Estimated Primary Completion Date | December 2003 |
| Current Primary Outcome Measures | This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks. [Time Frame: over the course of 52 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | MK0767 will be safe and well tolerated. [Time Frame: over the course of 52 weeks] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)(COMPLETED) |
|---|---|
| Official Title | A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise |
| Brief Summary | The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: MK0767 Duration of Treatment: 52 Weeks Other Names: MK0767Drug: Comparator: placebo (unspecified) Duration of Treatment: 52 Weeks Drug: Comparator: metformin Duration of Treatment: 52 Weeks |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 382 |
| Estimated Completion Date | December 2003 |
| Estimated Primary Completion Date | December 2003 |
| Eligibility Criteria | Inclusion Criteria: - Patients are men and non-pregnant women ages 21 to 78 years - Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study Exclusion Criteria: - Patient has history of type 1 diabetes mellitus and or history of ketoacidosis - Patients undergoing surgery within 30 days of Visit 1 - Patients taking Warfin or Warfin-like anticoagulants - Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9 |
| Gender | Both |
| Ages | 21 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00543361 |
|---|---|
| Other Study ID Numbers | 0767-020 |
| 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 |