Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
Overview[ - collapse ][ - ]
| Purpose | This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Vildagliptin Drug: metformin |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Responsible Party | Novartis |
| ClinicalTrials.gov Identifier | NCT00396357 |
| First Received | November 2, 2006 |
| Last Updated | December 28, 2012 |
| Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 2, 2006 |
|---|---|
| Last Updated Date | December 28, 2012 |
| Start Date | October 2006 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment [Time Frame: 24 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone |
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| Official Title | A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy |
| Brief Summary | This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes. |
| 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, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Vildagliptin Drug: metformin |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 914 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | June 2008 |
| Eligibility Criteria | Inclusion Criteria: - 18-78 years inclusive - Type 2 diabetes diagnosis at least 2 months prior to study entry - Body mass index in the range of 22-45 kg/m2 - HbA1c in the range of 6.5 to 9% inclusive - Fasting plasma glucose <270 mg/dL (15 mmol/L) Exclusion Criteria: - A history of type 1 diabetes - Evidence of significant diabetic complications - Treatment with insulin or any other oral antidiabetic agents - Congestive heart failure requiring pharmacologic treatment - Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females) Other protocol-defined inclusion/exclusion criteria may apply |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00396357 |
|---|---|
| Other Study ID Numbers | CLAF237A23104 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Novartis |
| Study Sponsor | Novartis Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals |
| Verification Date | December 2012 |
Locations[ + expand ][ + ]
| Novartis Pharmaceuticals | East Hanover, New Jersey, United States, 07936 |
|---|---|
| Novartis Investigative Site | Investigative Centers, Germany |