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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00237250 |
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.
Condition | Intervention | Phase |
---|---|---|
Prediabetic State |
Drug: vildagliptin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance |
Estimated Enrollment: | 170 |
Study Start Date: | October 2005 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Novartis Pharmaceuticals | |
East Hanover, New Jersey, United States, 07936 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Study ID Numbers: | CLAF237A2357 |
Study First Received: | October 9, 2005 |
Last Updated: | January 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00237250 |
Health Authority: | United States: Food and Drug Administration |
Pre-diabetes vildagliptin IGT |
Metabolic Diseases Hyperglycemia Glucose Intolerance Prediabetic State 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 |