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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00396227 |
This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: vildagliptin Drug: thiazolidinedione (TZD) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Open-Label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-Based Practice Setting. |
Enrollment: | 2665 |
Study Start Date: | October 2006 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Vildagliptin 100mg + Met
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Drug: vildagliptin
vildagliptin as add-on to metformin
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TZD: Active Comparator
TZD + metformin
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Drug: thiazolidinedione (TZD)
TZD add-on to metformin
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
United States, New Jersey | |
Novartis Pharmaceuticals | |
East Hanover, New Jersey, United States, 07936 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CLAF237A23119 |
Study First Received: | November 2, 2006 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00396227 |
Health Authority: | United States: Food and Drug Administration |
Type 2 diabetes vildagliptin hemoglobin A1c metformin |
Metabolic Diseases Pioglitazone Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus 2,4-thiazolidinedione |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Vildagliptin Rosiglitazone |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |