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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00386100 |
This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits).
Condition | Intervention | Phase |
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Non-Insulin-Dependent Diabetes Mellitus Type 2 Diabetes Mellitus |
Drug: Rosiglitazone maleate/metformin hydrochloride (AVANDAMET) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Parallel Group, Double-Blind, Multi-Center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment. |
Estimated Enrollment: | 588 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | AVT105913 |
Study First Received: | October 9, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00386100 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Type 2 diabetes mellitus Hyperglycemia HbA1c Drug-naive |
Metabolic Diseases Hyperglycemia 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 |