Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)
Overview[ - collapse ][ - ]
Purpose | This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy. |
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Condition | Type 2 Diabetes |
Intervention | Drug: Metformin Drug: vildagliptin |
Phase | Phase 4 |
Sponsor | Novartis Pharmaceuticals |
Responsible Party | Novartis |
ClinicalTrials.gov Identifier | NCT01541956 |
First Received | February 24, 2012 |
Last Updated | January 14, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | February 24, 2012 |
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Last Updated Date | January 14, 2014 |
Start Date | February 2012 |
Estimated Primary Completion Date | December 2013 |
Current Primary Outcome Measures | Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin [Time Frame: baseline, 24 weeks] [Designated as safety issue: No]The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION) |
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Official Title | An Open-labeled, Randomized, Multicenter, Prospective, Parallel Group, Interventional Study to Demonstrate the Effectiveness of 24 Weeks Treatment With Vildagliptin 50mg Bid as Add on to Metformin 500 mg Bid Compared to Metformin up to 1000 mg Bid in Chinese Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy . |
Brief Summary | This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | Drug: Metformin 500 mg twice daily Drug: vildagliptin Vildagliptin 50 mg twice daily Other Names: LAF237 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 3091 |
Estimated Completion Date | December 2013 |
Estimated Primary Completion Date | December 2013 |
Eligibility Criteria | Inclusion Criteria: - Chinese T2D patients who are inadequate controlled (6.5 %< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks), Exclusion Criteria: - Type 1 diabetes and secondary diabetes - Acute metabolic diabetic complications within the past 3 months. - Acute infections which may influence glucose level. - Evidence of significant chronic diabetic complications, - Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis, - FPG > 270 mg/dl (15 mmol/l) - Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF) Other protocol-defined inclusion/exclusion criteria may apply |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01541956 |
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Other Study ID Numbers | CLAF237ACN01 |
Has Data Monitoring Committee | No |
Information Provided By | Novartis |
Study Sponsor | Novartis Pharmaceuticals |
Collaborators | Not Provided |
Investigators | Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Novartis Investigative Site | Beijing, China, 100028 |
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