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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00044460 |
The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.
Condition | Intervention | Phase |
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Non-Insulin-Dependent Diabetes Mellitus |
Drug: rosiglitazone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24-Week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus |
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 Trial, MD, PhD | GlaxoSmithKline |
Study ID Numbers: | 49653/326 |
Study First Received: | August 29, 2002 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00044460 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Mexico: National Institute of Public Health, Health Secretariat |
Type 2 diabetes drug-naive |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Rosiglitazone Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Rosiglitazone Pharmacologic Actions |