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Sponsors and Collaborators: |
Bristol-Myers Squibb AstraZeneca |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00683878 |
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: Dapagliflozin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone |
Enrollment: | 420 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Dapagliflozin
Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
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Arm 2: Experimental |
Drug: Dapagliflozin
Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
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Arm 3: Placebo Comparator |
Drug: Placebo
Tablets, Oral, 0 mg, once daily, up to 48 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | MB102-030 |
Study First Received: | May 22, 2008 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00683878 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; India: Central Drugs Standard Control Organization; Mexico: Federal Commission for Protection Against Health Risks; Peru: Instituto Nacional de Salud (INS); Philippines: Bureau of Food and Drugs; Taiwan: Department of Health; United States: Food and Drug Administration |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus 2,4-thiazolidinedione |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Diabetes Mellitus |
2,4-thiazolidinedione Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |