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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00379769 |
This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or an Su (glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background Su will be randomised to receive, in addition to Su, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and Su at entry will be entered into the study.
Condition | Intervention | Phase |
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Type II Diabetes |
Drug: rosiglitazone Drug: metformin Drug: sulfonylurea |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulphonylurea With Metformin Plus Sulphonylurea on Cardiovascular Endpoints and Glycaemia |
Estimated Enrollment: | 4452 |
Study Start Date: | April 2001 |
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | BRL-049653/231 |
Study First Received: | September 21, 2006 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00379769 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
diabetes rosiglitazone metformin sulfonylurea |
Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Rosiglitazone Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Rosiglitazone Pharmacologic Actions |