Dose-Range Finding Study for MK0893 (0893-008)
Overview[ - collapse ][ - ]
Purpose | A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus). |
---|---|
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: MK0893 Drug: Metformin Drug: Placebo to MK0893 Drug: Placebo to Metformin |
Phase | Phase 2 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00479466 |
First Received | May 25, 2007 |
Last Updated | October 15, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | May 25, 2007 |
---|---|
Last Updated Date | October 15, 2013 |
Start Date | July 2007 |
Estimated Primary Completion Date | May 2008 |
Current Primary Outcome Measures | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) [Time Frame: Week 12] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Dose-Range Finding Study for MK0893 (0893-008) |
---|---|
Official Title | A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
Brief Summary | A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus). |
Detailed Description | Not Provided |
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: MK0893 MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose. Drug: Metformin Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks. Drug: Placebo to MK0893 Dose-matched placebo tablets to MK0893; taken orally once daily. Drug: Placebo to Metformin Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily. |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
---|---|
Estimated Enrollment | 342 |
Estimated Completion Date | May 2008 |
Estimated Primary Completion Date | May 2008 |
Eligibility Criteria | Inclusion Criteria: - Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy Exclusion Criteria: - Patients have a history of Type 1 Diabetes Mellitus - Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor [PPAR]-gamma agonist) - Patients who have a contraindication to metformin |
Gender | Both |
Ages | 21 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00479466 |
---|---|
Other Study ID Numbers | 0893-008 |
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 | October 2013 |