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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00679939 |
The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Rosiglitazone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study With a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA TM on Bone in Postmenopausal Women With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 226 |
Study Start Date: | April 2008 |
Ages Eligible for Study: | 55 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials Call Centre, MD, MPH | GlaxoSmithKline |
Study ID Numbers: | AVD111179 |
Study First Received: | May 15, 2008 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00679939 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Type 2 diabetes mellitus bone bone mineral density |
bone biomarkers dual-energy x-ray absorptiometry |
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 |