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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00138567 |
This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: vildagliptin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes |
Estimated Enrollment: | 530 |
Study Start Date: | January 2005 |
Ages Eligible for Study: | 18 Years to 78 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Novartis Pharmaceuticals | |
East Hanover, New Jersey, United States, 07936 | |
Germany | |
Investigative Centers, Germany |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Study ID Numbers: | CLAF237A2309E1 |
Study First Received: | August 27, 2005 |
Last Updated: | November 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00138567 |
Health Authority: | United States: Food and Drug Administration |
Type 2 diabetes vildagliptin |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Vildagliptin |
Dipeptidyl-Peptidase IV Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |