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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00333723 |
This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As microvascular and macrovascular disease are significant contributors to diabetes morbidity and mortality and previous studies suggest that the thiazolidinedione compounds could have potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum parameters associated with endothelial dysfunction, vascular inflammation and impaired fibrinolysis were examined in this study. Improvement in these parameters suggests that rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to improve glycemic control.
Condition | Intervention | Phase |
---|---|---|
Non-Insulin-Dependent Diabetes Mellitus |
Drug: Rosiglitazone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24-Week Randomized, Double-Blind Study to Evaluate the Efficacy, Safety and Tolerability of AVANDIA (8mg Once Daily) in Combination With Glyburide in African American and Hispanic Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Glyburide Monotherapy |
Enrollment: | 245 |
Study Start Date: | July 2000 |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Chair: | GSK Clinical Trials, MD | Glaxosmithline |
Study ID Numbers: | 49653/143 |
Study First Received: | June 2, 2006 |
Last Updated: | August 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00333723 |
Health Authority: | United States: Food and Drug Administration |
Rosiglitazone Type 2 Diabetes Mellitus Glyburide African American Hispanic |
Glyburide Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Rosiglitazone |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |