Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Comparator: Sitagliptin Drug: Comparator: Placebo Drug: Comparator: Pioglitazone Drug: Metformin |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00086502 |
| First Received | July 2, 2004 |
| Last Updated | May 27, 2010 |
| Last verified | May 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 2, 2004 |
|---|---|
| Last Updated Date | May 27, 2010 |
| Start Date | June 2004 |
| Estimated Primary Completion Date | November 2005 |
| Current Primary Outcome Measures | Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [Time Frame: Baseline and week 24] [Designated as safety issue: No]HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. |
| Current Secondary Outcome Measures | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [Time Frame: Baseline and week 24] [Designated as safety issue: No]Change from baseline at Week 24 is defined as Week 24 minus Week 0. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus |
|---|---|
| Official Title | A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy |
| Brief Summary | The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus. |
| 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 | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Comparator: Sitagliptin Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24 Other Names: JanuviaDrug: Comparator: Placebo Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24 Drug: Comparator: Pioglitazone Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8 Other Names: ACTOSDrug: Metformin Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8 Other Names: Metformin |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 353 |
| Estimated Completion Date | November 2005 |
| Estimated Primary Completion Date | November 2005 |
| Eligibility Criteria | Inclusion Criteria: - Patient has type 2 diabetes mellitus (T2DM) - Patient is 18 years of age (or older) - Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period Exclusion Criteria: - Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis - Patient required insulin within the prior 8 weeks - Patient is on a weight loss program and is not in the maintenance phase - Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks - Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate) - Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease - Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis) - Patient has any of the following disorders within the past 6 months: Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder. - Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months - Patient has severe peripheral vascular disease - Patient has congestive heart failure - Patient is HIV positive - Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - Patient has a history of neoplastic disease - Patient has a history of alcohol or drug abuse within the past 3 years - Patient has viral hepatitis (hepatitis B or C) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00086502 |
|---|---|
| Other Study ID Numbers | 2006_410 |
| 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 | May 2010 |