Home > Protocol Summaries: Compounds > rosiglitazone Protocol Summaries: rosiglitazone GSKStudy ID Phase Title Status 100684 phase 4 phase IV, multicenter, Single-blind, positive-controlled, parallel group study of glibenclamide (dose to be titrated from starting dose of 5mg om) plus rosiglitazone 4mg om (increased to 8mg om after 6 months) and vs glibenclamide (dose to be titrated with starting dose of 5mg om) plus placebo, adm Completed 104385 Phase 1 A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo. Completed 105407 phase 4 A multi-center, epidemiologic survey to describe the current medical practice of general practitioners treating subjects with type 2 diabetes mellitus in Latin America Completed 105640 phase 3 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1) Completed 111261 phase 4 Impact of ADA Treatment Guidelines for Type 2 Diabetes on Adherence and Economic Outcomes: Avandia plus Metformin therapy vs. Sulfonylurea plus Metformin therapy among Persistent Patients Completed 111262 phase 4 Resource utilization and costs associated with use of rosiglitazone versus insulin as add-on therapy to metformin users in the Veterans Administration Terminated 111802 Phase 1 A study to evaluate the effect of extended release Rosiglitazone (RSG XR) on cardiac conduction as compared to placebo and a single oral dose of moxifloxacin Withdrawn 111960 phase 4 Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease Terminated 112611 phase 4 Prescription Patterns, Resource Utilization & Costs - Add-on Therapy with Anti Dipeptidyl Peptidase-IVs vs rosiglitazone Completed 112684 phase 1 Validation Study of Simultaneous Administration of Multiple Cytochrome P450/Transporter Probes for Drug Interaction Evaluation in Healthy Adult Subjects Completed 113332 n\a The association between exposure to spironolactone or amiloride and fracture risk among subjects treated with thiazolidinediones Completed 114769 n\a A Meta Analysis of malignancy serious adverse events in the ADOPT, 49653/048, and RECORD, 49653/231, studies, comparing metformin with rosiglitazone. Completed 115170 phase 4 Blinded, Re-adjudication of Mortality and Major Cardiovascular Endpoints (MACE) from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of glycaemia in Diabetes trial (RECORD) Completed 116276 n\a Utilization of Rosiglitazone in Triple Therapy and Insulin Combinations, and Estimated Rates of Adverse Events in Rosiglitazone Recipients in Canada, 2004-2010 Completed 200065 Glucagon-like peptide-1 (GLP-1) agonists: Treatment utilization patterns and risk of acute pancreatitis Active not recruiting 49653.347 Phase 4 A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (2mg and 4mg) Compared to Insulin Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin. Completed 49653/048 phase 3 A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients with Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus Completed 49653/143 Phase 4 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 Completed 49653/284 Phase 4 A 24-Week Randomized, Double-blind, Double-Dummy, Multicenter Study to Compare the Efficacy of AVANDIA when added to Submaximal Doses of Metformin and to Compare the Tolerability of the Combination to Metformin Monotherapy when Administered to Subjects with Type 2 Diabetes Mellitus Completed 49653/326 Phase 4 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 Active, not recruiting 49653/334 Phase 4 See Detailed Description Completed 49653/342 phase 4 See Detailed Description Completed 49653/347 phase 4 A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (2mg and 4mg) Compared to Insulin Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who are Inadequately Controlled on Insulin Completed 49653/375 Phase 3 A single-centre, randomised, double-blind, placebo controlled, two 12 week period, cross-over phase III study to investigate the effect of rosiglitazone 4mg bd on the vasodilator response to hyperinsulinaemia in obese insulin resistant subjects. Completed 49653/376 Phase 3 A 16-week, randomised, double-blind, placebo-controlled, single-centre study to investigate fluid retention in insulin-treated subjects with type 2 diabetes mellitus and varying degrees of autonomic neuropathy when administered rosiglitazone 4 mg bd Completed ARA102198 phase 2 A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis Completed AVA100930 phase 2 A double-blind, randomised, placebo-controlled, parallel-group study to investigate the effects of Rosiglitazone (extended release tablets) on cerebral glucose utilisation and cognition in subjects with mild to moderate Alzheimers Disease (AD) Terminated AVA102670 phase 3 A 54-week, study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to acetylcholinesterase inhibitors on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease (REFLECT-3) Completed AVA102672 phase 3 A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to donepezil on cognition and overall clinical response in APOE ε4-stratified subjects with mild to moderate Alzheimer’s disease. Completed AVA102675 phase 3 An open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimers disease (REFLECT-4). Terminated AVA102677 phase 3 An open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) in subjects with mild-to-moderate Alzheimer's disease (REFLECT-5) Terminated AVA104617 phase 2 An open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease Completed AVA109939 phase 1 A two cohort study in healthy volunteers to characterise the pharmacokinetic properties of the Rosiglitazone XR formulation manufactured at the GlaxoSmithKline Crawley facility. Completed AVA109941 Phase 1 An open label, single oral dose study in patients with mild Alzheimer''s disease to assess the of Extended Release formulation of Rosiglitazone (RSG XR) in this population Completed AVD100521 phase 3 A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone versus Glipizide on the Progression of Atherosclerosis in Subjects with Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH) Completed AVD102209 phase 3 A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin Completed AVD104742 phase 3 Clinical evaluation of Rosiglitazone Malate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo - Completed AVD105248 Phase 3 Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Combination Therapy with SU) - A Placebo-Controlled Double-Blind Study - Completed AVD105720 Phase 3 Clinical evaluation of Rosiglitazone Malate (BRL49653C) in patients with type 2 diabetes mellitus -Long-term study of Rosiglitazone Maleate- Completed AVD111179 phase 4 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 Completed AXR107453 Phase 1 An Open-Label, Randomized, two-Period Crossover Study to Demonstrate the Bioequivalence of a Tablet Formulation of Rosiglitazone XR (BRL-049653) 8mg manufactured at two different sites in healthy volunteers in fasting conditions Completed BRL-049563/351 Phase 3 See Detailed Description Completed BRL-049653/231 phase 3 A long term, open label, randomised study in patients with type 2 diabetes, comparing the combination of rosiglitazone and either metformin or sulfonylurea with metformin plus sulfonylurea on cardiovascular endpoints and glycaemia Completed BRL-49653/137 Phase 3 A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects with Type 2 Diabetes Mellitus Completed BRL-49653/461 phase 2 A double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) on cerebral glucose utilization and cognition in subjects with mild to moderate Alzheimer's Disease (AD) Completed DIX110434 phase 1 See Detailed Description Completed
