Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Vildagliptin 100 mg qd Drug: Metformin 1500 mg daily |
Phase | Phase 3 |
Sponsor | Novartis Pharmaceuticals |
Responsible Party | Novartis |
ClinicalTrials.gov Identifier | NCT00383578 |
First Received | September 29, 2006 |
Last Updated | January 2, 2013 |
Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 29, 2006 |
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Last Updated Date | January 2, 2013 |
Start Date | September 2006 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Change from baseline in HbA1c [Time Frame: after 24 weeks of treatment] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes |
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Official Title | A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes |
Brief Summary | This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive 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, Investigator), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Vildagliptin 100 mg qd Drug: Metformin 1500 mg daily |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 335 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | May 2008 |
Eligibility Criteria | Inclusion Criteria: - Age from 65 years to the upper age limit recommended by local prescribing information for metformin - Drug naive patients with type 2 diabetes. - Body mass index (BMI) in the range of 22-40 kg/m2. - HbA1c in the range of 7 to 9% inclusive - FPG <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 Other protocol-defined inclusion/exclusion criteria may apply |
Gender | Both |
Ages | 65 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Germany, Switzerland |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00383578 |
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Other Study ID Numbers | CLAF237A2398 |
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 | January 2013 |
Locations[ + expand ][ + ]
Investigative Centers | Nurnberg, Germany |
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Novartis Pharmaceuticals | Basel, Switzerland |