Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)(COMPLETED)
Overview[ - collapse ][ - ]
| Purpose | This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin. |
|---|---|
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Sitagliptin Drug: Comparator: Placebo Drug: Pioglitazone Drug: Metformin Drug: Glipizide |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00885352 |
| First Received | April 20, 2009 |
| Last Updated | August 21, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 20, 2009 |
|---|---|
| Last Updated Date | August 21, 2013 |
| Start Date | April 2009 |
| Estimated Primary Completion Date | November 2010 |
| Current Primary Outcome Measures | Change From Baseline in Hemoglobin A1c (A1C) at Week 26 [Time Frame: Baseline and Week 26] [Designated as safety issue: No]Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)(COMPLETED) |
|---|---|
| Official Title | A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and Pioglitazone |
| Brief Summary | This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Sitagliptin Sitagliptin 100 mg tablet orally once daily for 26 weeks. Other Names:
Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks. Drug: Pioglitazone Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable period followed by a 2-week single-blind run-in and a 26-week treatment period. Participants taking 4 mg or more rosiglitazone oral tablet(s) daily at screening in combination with metformin were to be switched to a corresponding dose of pioglitazone prior to starting a 4-week dose-stable period. Participants who are taking less than 30 mg/day or no pioglitazone at screening will be titrated to a stable dose of at least 30 mg pioglitazone once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with pioglitazone will be up to 42 weeks. Other Names: ActosDrug: Metformin Participants taking 1500 mg or more metformin oral tablet(s) and at least 30 mg pioglitazone or 4 mg rosiglitazone daily at screening will enter a 4-week dose-stable period followed by a 2-week single-blind placebo run-in, and a 26-week treatment period. Participants who are taking less than 1500 mg/day metformin at screening will be titrated to a stable dose of at least 1500 mg metformin once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with metformin will be up to 42 weeks. Other Names: GlucophageDrug: Glipizide Participants not meeting specific glycemic controls during the 26-week treatment period will use glipizide oral tablets as rescue therapy. In countries where glipizide is not available, participants will receive a sulfonylurea marketed in that country. Other Names: Glucotrol |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 313 |
| Estimated Completion Date | November 2010 |
| Estimated Primary Completion Date | November 2010 |
| Eligibility Criteria | Inclusion Criteria: - has type 2 diabetes and is at least 18 years of age and no older than 78 years of age - is male or is a female who is unlikely to conceive children - is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and metformin OR metformin and a sulfonylurea agent Exclusion Criteria: - has type 1 diabetes - has taken a dipeptidyl peptidase (DPP-4) inhibitor or a glucagon-like peptide-1 (GLP-1) analogue - is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening - has had surgery within 30 days of screening or has major surgery planned during the study - is on or is likely to require treatment with corticosteroids for more than 2 weeks - has a history of active liver disease, including hepatitis B or C, cirrhosis, or gallbladder disease - is human immunodeficiency virus (HIV) positive - has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening - has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening - has severe active peripheral vascular disease - has a history of cancer or blood disorder - is pregnant or breast feeding |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00885352 |
|---|---|
| Other Study ID Numbers | 0431-128 |
| Has Data Monitoring Committee | No |
| 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 | August 2013 |