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Study 16 of 529 for search of: | Australia, Western Australia |
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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00499707 |
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: rosiglitazone maleate/metformin hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects |
Estimated Enrollment: | 453 |
Study Start Date: | October 2003 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 712753/007 |
Study First Received: | July 9, 2007 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00499707 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Drug-naive HbA1c type 2 diabetes |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Rosiglitazone |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |