Rosiglitazone has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Rosiglitazone Studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
100684 (SB-49653/454) IV A Single-blind, Randomised, Positive-controlled, Parallel-group Multicentre Study to Compare the Effect of Glibenclamide plus Rosiglitazone vs Glibenclamide plus Placebo on Body Fat Distribution When Administered for 12 Months to Korean Patients with Type 2 Diabetes Mellitus.
362-01 (49653/362) IV A 12-Week Randomized, Double-Blind, Local Multicenter, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Rosiglitazone (BRL 49653C) When Administered Once Daily To Patients With Type-2 Diabetes Mellitus (T2DM) Who Are Inadequately Controlled On At Least Half Maximal Dose of Usual Sulphonylurea
49653/143 IV A 24-week randomized, double-blind study to evaluate the efficacy, safety and tolerability of rosiglitazone (RSG) (8mg once daily) in combination with glyburide in African American and Hispanic subjects with type 2 diabetes mellitus who are inadequately controlled on glyburide monotherapy.
49653/171 IV An open-label, non-comparative multi centre study to obtain further information on the efficacy and safety of rosiglitazone as monotherapy when administered to Asian patients with Type 2 Diabetes Mellitus.
49653/177(AVA-177/2000) IV AVA-177: AvandiaÒ in daily practice.
49653/203 IV A post-marketing surveillance study of Avandia (Rosiglitazone) in the treatment of Filipino patients with type 2 diabetes
49653/211 IV A 52-week double-blind study of the effect of rosiglitazone on cardiovascular structure and function in subjects with type 2 diabetes mellitus and congestive heart failure (NYHA class I/II)
49653/267(extension-term) IV A multi-center, open-label extension study to assess the safety and efficacy of rosiglitazone as monotherapy or in combination with concurrent metformin or sulphonylurea therapy when administered to patients with type 2 diabetes.
49653/267(short-term) IV A multi-center, open-label study to assess the safety and efficacy of rosiglitazone (RSG) as monotherapy or in combination therapy with concurrent Metformin (Met) or Sulphonylurea (SU) when administered to Chinese patients with Type 2 diabetes.
49653/284 IV 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
49653/295(AVA-295/2001) IV AVA-295: AvandiaÒ in daily practice.
49653/326 IV A 24-Week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Regimens, 4 mg OD and 8 mg OD, in Poorly-Controlled Drug Naïve Patients with Type 2 Diabetes Mellitus
49653/329 (AVA-329/2001) IV AVA-329: AvandiaÒ in daily practice.
49653/390 IV An Open-label study to assess the efficacy and safety of rosiglitazone with concurrent sulphonylurea therapy when administered to subjects with type 2 diabetes mellitus.
49653/393 IV A 26-week Open Label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maximum Dose of Metformin (2.5 g/day) or Sulfonylureas (maximum dose/day).
49653/432 IV A 24-week Open-Label, Multicenter, Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered to Subjects with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (1.5 to 2.5 g/day) of Metformin.
712753/008 IV Rosiglitazone Maleate plus Metformin Hydrochloride Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of Rosiglitazone Maleate plus Metformin Hydrochloride to Metformin Monotherapy in Subjects with Type 2 Diabetes Mellitus Who are not Achieving Glycemic Control on Submaximal Metformin
AVA371 IV Influence of guideline-compliant treatment of diabetes mellitus type 2 on effectiveness and costs (LEADIT/ADIT)
AVALON IV Avandia Longitudinal Observational Network (AVALON)
AVM-001/2003 IV GREAT (German Recent Evaluation of Avandamet Treatment)-Post Marketing Surveillance (PMS) A PMS study of Avandamet® ( FDC rosiglitazone plus metformin) in the treatment of German patients with type 2 diabetes mellitus (T2DM)
AVM100264 IV A randomised, multi-centre, phase IV, double-blind, parallel group study comparing the effects of 52 weeks' administration of AVANDAMET* and metformin plus sulphonylurea on change in HbA1c from baseline in overweight type 2 diabetics poorly controlled on metformin.
BRL 49653C/185 IV Rosiglitazone Evaluation: Advancing Canadian Treatment of Type 2 Diabetes (REACT 2)
BRL-049653/282 IV A Double-Blind Feasibility Study to Estimate and Compare the Effect of Rosiglitazone in Parallel with Glyburide on Cognition in Patients with Type 2 Diabetes Mellitus
BRL-049653/311 IV A 12-Week, Randomized, Double-blind Study to Evaluate the Effects of Rosiglitazone 4 mg BD and Rosiglitazone 4 mg QD on Lipids in Type 2 Diabetes Mellitus Subjects Taking Statins
BRL-049653/334 IV RAS Rosiglitazone and Atherosclerosis Study: A 1 year randomised, double-blind, parallel group, placebo controlled study to evaluate the efficacy of rosiglitazone on the progression of intima-media thickness in the carotid artery in subjects with insulin resistance syndrome and/or type 2 diabetes mellitus
BRL-049653/347 IV 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.
BRL-049653/369 IV A six-month double-blind, randomised, parallel-group study to compare the effect of oral rosiglitazone (less than or equal to 4mg bd) versus oral glibenclamide therapy (less than or equal to 15mg daily) on body fat distribution when administered to subjects with type 2 diabetes mellitus
DIX110825 IV A Single Center, Single Sequence, Open-Label, Repeat-Dose Study to Investigate the Effect of XXX investigational drug on Hepatic Cytochrome P450 Activity in Healthy Adult Subjects
FGSS IV A 52-week pharmacovigilance study to assess the safety of oral prescription medicine AVANDIA™ (rosiglitazone) 4mg and 8mg daily in conjunction with sulfonylurea or metformin, in patients with type-2 diabetes mellitus.
RO12003 IV Efficacy and Safety of Rosiglitazone in the Treatment of Type 2 Diabetes Mellitus
ROSF4003 (101732) IV AVANTAGE: Monitoring a patient cohort treated with Avandia – Evaluation of safety data.
WE145 IV An Assessment of the Effect of Thiazolidinedione Exposure on the Risk of Myocardial Infarction in Type 2 Diabetic Patients
WE186 IV Rosiglitazone - Prescription Event Monitoring (PEM) Study
WE808086 IV Balanced cohort study of thiazolidinediones (TZDs) and other anti-diabetic therapies and coronary heart disease (CHD) outcomes
WEUS253 IV Incidence of Neoplasms in Rosiglitazone Clinical Trials
WEUS270 IV Cancer Incidence among Patients Treated with Antidiabetic Pharmacotherapy
WEUSRTP2181 IV Fracture diagnoses in patients receiving monotherapy with antidiabetic agents, including hand and foot fractures
WEUSRTP2489 IV Cohort Study of Thiazolidinediones (TZDs) and other Anti-diabetic Therapies and Coronary Heart Disease Outcomes
049653/109 III An Open-label, Positive-controlled, Parallel-group Study to Determine the Effect of BRL 49653C, Rosiglitazone, on Body Fat Distribution When Administered for 26 Weeks to Patients with Type 2 Diabetes
49653/009 III A Multicentre, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of Rosiglitazone When Administered to Patients With Type 2 Diabetes Mellitus
49653/011 III A 26-Week Randomized, Double-blind, Multicenter, Placebo-Controlled, Comparison Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy when Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM)
49653/015 III A Multicentre, Double-Blind, Placebo Controlled, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone with Concurrent Sulphonylurea therapy, When Administered to Patients with Type 2 Diabetes Mellitus.
49653/020 III A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone vs. Glibenclamide Therapy, When Administered to Patients with Type 2 Diabetes Mellitus.
49653/024 III A 26-week Randomized, Double-blind, Multicenter, Placebo-Controlled, Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone Therapy When Administered to Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM) Using a Once Daily Dosing Regimen, and to Determine the Therapeutic Equivalence of the Once and Twice Daily Dosing Regimens.
49653/025 III A Multicentre, Double-Blind, Parallel Group Study to Determine the Effects of Rosiglitazone on Insulin Sensitivity, Endothelial Function and Vascular Reactivity in Comparison With Metformin and Placebo When Administered to Patients With Non-insulin Dependent Diabetes Mellitus.
49653/044 III A 26-week Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BRL 49653C When Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Who Are Inadequately Controlled on a Maintenance Dose (2.5g/day) of Metformin "Twice daily add-on to metformin"
49653/079 III A 26-week Randomized, Double-Blind, Double-Dummy, Multicentered Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maximal Dose (20 mg/day) of Glyburide.
49653/080 III A 3 Year Open-label, Multicenter, Active (Glyburide) Comparison Study to Evaluate the Effect of Rosiglitazone on Cardiovascular Function in Patients with Non-insulin Dependent Diabetes Mellitus (NIDDM)
49653/082 III A 26-Week Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of BRL 49653C when Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on Insulin Monotherapy
49653/083 III Investigation of the effects of the thiazolidinedione, rosiglitazone, on regional adiposity, intrahepatic fat and muscle insulin sensitivity in type 2 diabetic patients (TRIM)
49653/084 III An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of BRL 49653C when Administered as Monotherapy, Twice Daily, to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
49653/085 III A 26 Week Randomised, Double-Blind, Multicentre Study to Investigate the Effects of Rosiglitazone on Insulin Requirements in Insulin-Treated Type 2 Diabetic Patients
49653/090 III An 8-week Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Rosiglitazone (BRL 49653) Therapy when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) Using a Twice Daily Dosing Regimen
49653/091 III A Multicentre, Open Label Extension Study To Assess the Long Term Safety, Tolerability and Efficacy of Rosiglitazone when Administered as Monotherapy, Once Daily to Patients with Type 2 Diabetes Mellitus
49653/093 III A 26-Week Randomized, Double-Blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone 4mg twice daily when Administered to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (2.5mg/day) of Metformin
49653/094 III A 26-Week Randomized, Double-Blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on a Maintenance Dose (2.5 mg/day) of Metformin
49653/095 III A 26-week Randomised, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Type 2 Diabetes who are Inadequately Controlled on Insulin Monotherapy
49653/096 III A 26-week Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone when Administered Once Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on At Least Half-Maximal Dose (?10 mg/day) of Glyburide.
49653/097 III A 3-Year Open-Label, Multicenter, Active (Glyburide) Comparison Study, to Evaluate the Effect of BRL 49653C 8mg od on Cardiovascular Function in Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
49653/105 III An Open-label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of BRL 49653C When Administered as Monotherapy, Once Daily, to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
49653/108 III A 16-Week Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety and Efficacy of Hypolipidemic Therapy with an HMGCoA Reductase Inhibitor (Atorvastatin) in Type 2 Diabetes Mellitus Patients Treated with Rosiglitazone (BRL 49653C) 4mg bd
49653/112 III An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of Rosiglitazone When Administered Once or Twice Daily in Combination with Glyburide to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
49653/113 III An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of 49653 When Administered Once or Twice Daily in Combination with Metformin to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
49653/114 III An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of Rosiglitazone When Administered Once or Twice Daily in Combination with Insulin to Patients with Type 2 Diabetes
49653/125 III An Open-Label Study to Assess the Efficacy and Safety of Rosiglitazone with Concurrent Sulphonylurea Therapy when Administered to Subjects with Type 2 Diabetes
49653/127 III A 26-Week Randomized, Double-Blind Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone 8mg/day (4mg bd) Versus Placebo in Combination with Glyburide in Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum Dose Glyburide
49653/128 III A double-blind, multicenter, placebo controlled, parallel group comparative study to evaluate the efficacy and safety of BRL 49653C (Avandia) with concurrent sulphonylurea therapy, when administered to patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
49653/133 III An Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Efficacy of Rosiglitazone (BRL 49653C) When Administered Twice Daily in Combination with Glyburide to Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Maximum Dose Glyburide (from study 49653-127)
49653/134 III A 26-Week Randomized, Double-Blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone (2 mg BID and 4 mg BID) Versus Placebo in Combination with Glyburide and Metformin in Patients with Type 2 Diabetes Mellitus
49653/135 III 2-year, Randomized, Double-blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone Versus Placebo in Combination with Glipizide in Elderly Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled on Glipizide Therapy
49653/136 III A 26-week Randomised, Double-Blind, Multicentre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone with Concurrent Insulin Therapy and/or a Sulphonylurea in Type 2 Diabetic Patients with Chronic Renal Failure (Not on Dialysis).
49653/140 III A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Effects of Rosiglitazone on Post Prandial Glycaemia in Type 2 Diabetic Patients.
49653/145 III A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Rosiglitazone in Combination with Gliclazide Compared to Normal Upward Titration of Gliclazide in Patients with Type 2 Diabetes Mellitus.
49653/147 III A multicentre, double-blind, placebo-controlled, parallel group, comparative study to evaluate the efficacy, safety and tolerability of rosiglitazone with concomitant oral therapy with sulphonylurea when administered for 26 weeks to patients with type 2 diabetes and who are of Indo-Asian ethnic origin living within the United Kingdom
49653/154 III A multicentre, open label, comparative study to evaluate the efficacy, safety and tolerability of rosiglitazone + metformin vs glibencamide + metformin (fixed combination) in type 2 diabetic subjects fairly controlled on up to half maximal dose of monotherapy drugs and requiring tighter metabolic control.
49653/162 III A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Rosiglitazone in Combination with Glibenclamide Compared to Normal Upward Titration of Glibenclamide in Patients with Type 2 Diabetes Mellitus
49653/210 III An open-label, 16 weeks, non-comparative study to evaluate the efficacy and safety of Avandia (rosiglitazone) monotherapy, when administrated to patients with Type 2 Diabetes Mellitus (T2DM).
49653/234 III A 26-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Rosiglitazone in Combination with Glimepiride compared to Glimepiride Alone in Patients with Type 2 Diabetes Mellitus
49653/351 III Rosiglitazone and Plaque Study: A 12 Month Randomised, Double-blind, Placebo-controlled, Magnetic Resonance Imaging Study to Evaluate the Effect of Rosiglitazone on the Structure and Composition of Carotid Atherosclerotic Plaques in Subjects with Type 2 Diabetes Mellitus and Coexisting Vascular Disease or Hypertension
49653/423 III An Open-Label Study to Obtain Clinical Experience with BRL49653C with Concurrent Alpha-glucosidase Therapy in Patients with Type 2 Diabetes Mellitus
712753 / 100420 (Ziel Study) III A 24-week open study to investigate the effectiveness, tolerability and efficacy to reach HbA1c-goals of a new oral antidiabetic drug (Avandamet) in patients with type 2 diabetes with inadequate glycemic control under metformin monotherapy
AVD102209 III A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (4mg) Compared to Insulin Plus Placebo for 24 Weeks in Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin.
AVD104742 III Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Monotherapy) – Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo
AVD105248 III Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Combination Therapy with SU) – A Placebo-Controlled Double-Blind Study
AVD105720 III Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus - Long-Term Study of Rosiglitazone Maleate -
AVM100344 III A 28-Week, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Formulation X in Subjects with Type 2 Diabetes Mellitus
AVS101946 III A 16 week randomized, double-blind, and parallel group study to evaluate the efficacy and safety of a new medication to lower LDL-c and HbA1c in subjects with type 2 diabetes mellitus.
AXR100723 III A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus
BRL 49653/152 III A multicentre, open-label study (26 weeks) to evaluate the efficacy and tolerability of rosiglitazone when administered to patients with type 2 diabetes who are inadequately controlled with diet either alone or together with oral antidiabetic therapy
BRL 49653/157 III A multicentre, double-blind, randomised, parallel-group study of 26 weeks duration to assess the efficacy, safety and tolerability of Rosiglitazone compared to Acarbose in the treatment of Non-insulin dependent Diabetes Mellitus.
BRL 49653/392 III A 52 weeks open label, randomised, parallel group, multicentre study to investigate the effects of rosiglitazone or metformin on blood pressure when administered to subjects with Impaired Glucose Tolerance
BRL-049653/048 ADOPT III 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
BRL-049653/131 III A Double-blind, Placebo-controlled, Parallel-group Study to Determine the Effect of BRL- 49653C Rosiglitazone, on Fat Distribution When Administered for 26 Weeks to Subjects With Impaired Glucose Tolerance (IGT)
BRL-049653/183 III A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of Oral Formulation X and AVANDIA™ (4mg BD) in Patients with Type 2 Diabetes
BRL-049653/207 III A 24-week Randomized, Double-blind, Active-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rosiglitazone When Administered to Pediatric Patients with Type 2 Diabetes Mellitus
BRL-049653/325 III A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Rosiglitazone in Combination with Glimepiride Compared to Glimepiride Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who are Inadequately Controlled on Non-TZD Oral Monotherapy
BRL-049653/330 III A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Three Dose Levels of Rosiglitazone Maleate in the Treatment of Chronic Plaque Psoriasis
BRL-049653/331 III A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Rosiglitazone Maleate in the Treatment of Chronic Plaque Psoriasis
BRL-049653/342 III A randomised, open-label, parallel group study to evaluate the management of rosiglitazone-related fluid retention by investigating the effect of diuretics on plasma volume in subjects with type 2 diabetes mellitus treated for twelve weeks with rosiglitazone 4mg bd in addition to background anti-diabetic agents
BRL-049653/352 III A 16 Week Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effect of Rosiglitazone on Myocardial Glucose Uptake in Subjects with Type 2 Diabetes Mellitus and Stable Coronary Heart Disease
BRL-049653/375 III A single-centre, randomised, double-blind, placebo controlled, two 12-week period, crossover phase III study to investigate the effect of rosiglitazone 4mg bd on the vasodilator response to hyperinsulinaemia in obese insulin resistant subjects.
BRL-049653/376 III 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.
BRL-49653/137 III A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects with Type 2 Diabetes Mellitus
BRL49653C/374 III Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Combination Therapy with alpha- glucosidase inhibitor) – A Placebo-Controlled Double-Blind Study
HM2006/00497/00 / WEUSRTP866 III Coronary Heart Disease Outcomes in Patients Receiving Antidiabetic Agents
ROSF4002 – Interim Report III Interest of early combination with rosiglitazone in the optimised management of type 2 diabetic subjects poorly controlled with sulfonylurea or metformin monotherapy. OPTIMA study.
SB-712753/002 III A phase III, 24 week, multi-centre, randomised, double-blind, parallel group, dose escalation study of Avandamet (rosiglitazone/metformin) and high dose metformin monotherapy in subjects with poorly controlled type 2 diabetes mellitus
SB-712753/003 III A Phase III Multi-Centre, Double-Blind, Randomised, Parallel-Group, Dose Escalation Study Comparing the Effects of 32 Weeks Administration of Avandamet and Metformin on Hba1c Targets in Subjects With Mild Type 2 Diabetes Mellitus
SB-712753/004 III An open-label trial to evaluate the safety and efficacy of fixed dose rosiglitazone/metformin combination therapy in poorly-controlled subjects with type 2 diabetes mellitus
SB-712753/007 III A randomized, double-blind trial to evaluate the efficacy and safety of fixed dose rosiglitazone/metformin combination therapy compared to both rosiglitazone and metformin monotherapies in drug naive type 2 diabetes mellitus subjects
SB-712753/009 III A Phase III, 24 Week, Multi-Centre, Double-Blind, Randomised, Parallel Group Study Comparing the Effects of Avandamet (8mg/2000mg) Plus Insulin to Placebo Plus Insulin on Change in Hba1c, in Subjects With Type 2 Diabetes Starting Insulin Therapy
SB-797620/004 III A multi-center, randomized, double-blind, parallel group trial to compare the efficacy and safety of fixed-dose rosiglitazone/glimepiride combination therapy to glimepiride monotherapy and rosiglitazone monotherapy in drug naïve subjects with type 2 diabetes mellitus
ZM2005/00181/01 III Avandia Cardiovascular Event Modeling Project
49653/006 II A 12-Week, Multicenter, Double-Blind, Placebo-Controlled, Dose Response Study Assessing the Safety, Tolerability, and Efficacy of BRL 49653C in Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
49653/022 II A Double-Blind, Parallel Group Placebo-Controlled Study to Determine the Effects of Rosiglitazone on Insulin Resistance and Glucose Tolerance When Administered to Subjects with Impaired Glucose Tolerance.
49653/050 II A Clinical Evaluation of BRL49653C in Type-2 Diabetes Mellitus; An Early Phase II Open-label Study (Monotherapy)
49653/098 II A Multicentre, Double-Blind, Parallel Group, Placebo-Controlled Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone When Administered Once Daily to Patients with Type 2 Diabetes Mellitus
49653/132 II A Multicentre, Double-Blind, Placebo Controlled, Parallel Group Comparative Study to Assess the Efficacy and Safety of Rosiglitazone with Concurrent Sulphonylurea Therapy when Administered to Subjects with Non-Insulin-Dependent Diabetes Mellitus (Type 2 Diabetes)
49653/292 II A Randomized, Double-Blind, Placebo-Controlled Trial to Assess Three Dose Levels of Rosiglitazone Maleate in the Treatment of Moderate to Severe Plaque Psoriasis
49653/452 II A randomised, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability and efficacy of six months' administration of AVANDIA (rosiglitazone maleate) in subjects with Relapsing-Remitting Multiple Sclerosis (MS)
ARA102198 II 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
AVA100193 II A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease
AVA100468 II An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease
BRL49653C/051 II A Clinical Evaluation of BRL49653C in Non-insulin-dependent Diabetes Mellitus.
BRL49653C/054 II Clinical Evaluation of BRL49653C in Type-2 Diabetes Mellitus (Monotherapy) - Double-blind Dose-finding Study.
BRL49653C/055 II Clinical Evaluation of BRL49653C in Type-2 Diabetes Mellitus (Combination Therapy with Sulphonylurea) - Double-blind Dose-finding Study.
BRL49653C/151 II Clinical Evaluation of BRL49653C (BID) in Type-2 Diabetes Mellitus (Monotherapy) – Double-blind, dose response study.
BRL49653C/159 II Clinical Evaluation of BRL49653C twice daily in Type-2 Diabetes Mellitus (Combination therapy) – Double-blind, dose-finding study.
BRL49653C/160 II Clinical Evaluation of BRL49653C (BID) in Non-Insulin Dependent Diabetes Mellitus (Monotherapy) -Extension Study.
SB-999910/150 II A study in patients with Crohn's Disease to evaluate the effect of AVANDIA™ on inflammatory activity mediated by monocytes/macrophages.
49653/001 I Evaluation of the Safety, Tolerablity and Preliminary Pharmacokinetics of Single Rising Doses of BRL 49653C in Normal Volunteers
49653/002 I An Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BRL 49653 after 10 Days Repeat Dosing to Obese Subjects
49653/004 I Investigation of the Effect of Food on the Pharmacokinetics of BRL 49653C in Healthy Male Volunteers
49653/005 I A Single Dose Study to Assess the Safety, Tolerability, Dose Proportionality and Food Effect of the Proposed Commercial Tablet Formulation of BRL 49653C in Healthy Volunteers
49653/007 I An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Hemodialysis-Dependent Patients with End Stage Renal Disease Compared to Volunteers with Normal Renal Function
49653/008 I An Evaluation of the Safety, Tolerability, Pharmacokinetics and Protein Binding of BRL 49653C in Patients with Hepatic Impairment
49653/013 I A Study of the Effect of Age on the Pharmacokinetics of BRL 49653C in Healthy Volunteers.
49653/014 I A Study to Determine the Effect of BRL 49653C on Steady-State Pharmacodynamics and Pharmacokinetics of Glyburide in Non-Insulin Dependent Diabetic Patients
49653/016 I Evaluation of the Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 5, 10, 15 and 20 mg BRL 49653C in Healthy Male Volunteers
49653/017 I A Placebo-Controlled Single-Blind Study on the Safety, Tolerance and Pharmacokinetics of BRL49653C 1 mg, 2 mg, 4 mg, 8 mg and 16 mg in Single Oral Administration in Healthy Volunteers
49653/018 I Phase I Clinical investigation of 49653 (Series 2): A study on the effect of a Meal on the Pharmacokinetics of 49653 4 mg Administered Orally to Healthy Adult Volunteers
49653/019 I A Placebo-controlled Single-blind Study on the Safety, Tolerance and Pharmacokinetics of Single and 7-day (t.i.d.) Repeat Oral Administration of 49653 2mg in Healthy Adult Volunteers
49653/028 I Bioequivalence Study of the Final Market Formulation of BRL 49653C Compared to the Clinical Trials Formulation
49653/029 I Evaluation of the Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Intravenous Doses of BRL 49653C in Normal Volunteers
49653/030 I A Bioequivalence Study of BRL 49653C Proposed Final Market Tablet Formulation (formula AGAA) versus BRL 49653C Clinical Trials Capsule Formulation (formula AB-AA)
49653/031 I An Investigation of the Effect of BRL 49653C on the Safety, Tolerability and Pharmacokinetics of Oral Contraceptives in Healthy Female Volunteers
49653/034 I A Study to Assess the Effects of BRL 49653C on the Pharmacokinetics of Digoxin in Healthy Adult Males
49653/035 I A Study to Assess The Effect of BRL 49653C on the Anticoagulant Effect of Warfarin in Healthy Male Volunteers
49653/036 I A Study to Determine the Effect of BRL 49653C on the Pharmacokinetics of Metformin in Healthy Male Volunteers
49653/037 I A Study to Assess the Effect of Ranitidine on the Bioavailability of BRL 49653C in Healthy Adult Males
49653/038 I An Evaluation of the Pharmacokinetics of a Single Oral Dose of BRL 49653C in Patients with Varying Degrees of Renal Insufficiency Compared to Volunteers with Normal Renal Function
49653/039 I An Investigation of the Effect of BRL 49653C on the Safety, Tolerability and Pharmacokinetics of Nifedipine in Healthy Volunteers
49653/040 I Effect of Acarbose on the Pharmacokinetics of BRL 49653C in Healthy Adult Volunteers
49653/041 I A Study to Evaluate the Effect of Ethanol Administration on the Pharmacodynamics of BRL 49653C in Chronically-Treated Type 2 Diabetic Patients
49653/043 I Placebo-controlled, Double-Blinded Trial to Study the Absorptive and Post-Absorptive Skeletal Muscle and Hepatic Metabolic Effects of BRL-49653C After 12 weeks Treatment in Patients with Non-Insulin Dependent Diabetes Mellitus
49653/049 I A Study to Determine the Balance/Excretion, Pharmacokinetics and Biotransformation of BRL 49653 Given as a Single Oral (8 mg pfb) and Single Intravenous (2 mg pfb) Doses of [14C]-BRL 49653C to Healthy Male Adult Volunteers and Determine the Pharmacokinetics of a Single Oral Dose (2 x 4 mg Tablets) of BRL 49653C Given on a Third Occasion
49653/078 I A Placebo-controlled Study to Evaluate the Effect of Rosiglitazone on Plasma Volume and Red Blood Cell Volume in Healthy Volunteers
49653/087 I A Placebo-controlled Single-blind Study on the Safety, Tolerance and Pharmacokinetics of Single and 7-day (b.i.d.) Repeat Oral Administration of BRL49653C 4mg in Healthy Adult Volunteers
49653/101 I A placebo controlled single-blind study on the safety, tolerance and pharmacokinetics of single and 8-day (u.i.d) repeat oral administration of BRL 49653C 8 mg in healthy adult volunteers
49653/116 I An Investigation of the Effect of Rosiglitazone Maleate (BRL 49653C) Versus Troglitazone on the Safety, Tolerability and Pharmacokinetics of Triazolam in Healthy Volunteers
49653/121 I An Investigation of the Pharmacokinetics of Single 4 mg and Repeat 4 mg Twice Daily and Single and Repeat 8 mg Once Daily Doses of Rosiglitazone in Healthy Volunteers
49653/129 I An Evaluation of the Safety and Tolerability of Single Rising Doses of Rosiglitazone in Healthy Chinese male Subjects.
49653/130 I An Evaluation of the Safety, Tolerability and Pharmacokinetics of Rosiglitazone after 8 Days Repeat –Dosing to Healthy Chinese Subjects.
49653/142 I An evaluation of the Pharmacokinetics of Single Dose of Rosiglitazone in Healthy Chinese Male Subjects.
49653/161 I An evaluation of the pharmacokinetics of single doses of Rosiglitazone in healthy Taiwanese male subjects
49653/163 I A Single Dose Study to Assess the Safety, Tolerability and Bioequivalence of the 2 x 2 mg versus the 4 mg Commercial Tablet Formulations of Rosiglitazone in Healthy Male Japanese Volunteers
49653/166 I Evaluation of Safety and Pharmacokinetics of Single Dose of Rosiglitazone in Healthy Korean Male Volunteers
49653/206 I An open label, single center, randomized, cross-over study to determine the bioequivalence of the final market formulation of Rosiglitazone and the clinical trials formulation in Chinese subjects.
49653/224 I A Study to Examine the Effects of Alucol®, a Combination Magnesium/Aluminum Hydroxide-Containing Antacid, on the Pharmacokinetics of Rosiglitazone (8 mg).
49653/225 I A Double-Blind Study to Assess the Effect of Rosiglitazone (RSG) on the Pharmacodynamics and Pharmacokinetics of Acenocoumerol in Healthy Male Volunteers
49653/270 I A Bioequivalence Study With a Combination Tablet Formulation of Rosiglitazone and Metformin (4 mg/500 mg ) Compared to Concomitant Dosing of Rosiglitazone 4 mg and Metformin 500 mg Commercial Tablets and a Dose Proportionality Study Comparing the 4 mg/500 mg and 1 mg/500 mg Combination Formulations.
49653/271 I A Study to Assess the Effect of Food on the Pharmacokinetics of a Rosiglitazone 4 mg and Metformin 500 mg Combination Tablet Formulation and a Study Comparing the Pharmacokinetics of Rosiglitazone 4 mg and Metformin 500 mg Combination Tablet to Concomitant Dosing of Rosiglitazone 4 mg and Metformin 500 mg Commercial Tablets in the Fed State in Healthy Volunteers
49653/340 I A Study to Estimate the Effect of Repeat Oral Doses of Rosiglitazone (8 mg) on the Pharmacokinetics of Glimepiride (4 mg) and the Effect of a Single Oral Dose of Glimepiride (4 mg) on the Pharmacokinetics of Rosiglitazone (8 mg) in Healthy Subjects.
49653/414 I An open-label, non-randomized, two period study to investigate the pharmacokinetics of rosiglitazone and glibenclamide when administered alone and concomitantly in healthy male Japanese and Caucasian subjects.
49653/902 I An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosiglitazone when Co-administered with Gemfibrozil in Healthy Adult Subjects
797620/001 I A dose proportionality study with a combination tablet formulation of rosiglitazone and glimepiride (4 mg/1 mg; or 4 mg/2 mg; or 4 mg/4 mg) in healthy subjects.
999910/196 I A randomized, placebo-controlled, single blind, 4 way cross-over study to investigate the effects of a single dose of Avandia® on renal function in healthy male volunteers.
AVM103205 I A Bioequivalence Study With a Combination Tablet Formulation of Rosiglitazone and Metformin (2 mg/500 mg) Compared to Concomitant Dosing of Rosiglitazone 2 mg and Metformin 500 mg Commercial Tablets in Chinese Healthy Male Subjects.
AVS102130 I An Open-Label, Randomized, Four-Period Crossover Study in Healthy Subjects to Demonstrate the Bioequivalence of a Fixed Dose Combination Tablet Formulation of Rosiglitazone and Simvastatin (8mg/80mg) to Concomitant Dosing of Rosiglitazone 8mg and Simvastatin 80mg Commercial Tablets and to Assess the Pharmacokinetics of the Concomitant Dosing of Rosiglitazone 8mg and Simvastatin 80mg Commercial Tablets Relative to Commercial Rosiglitazone 8mg Alone, and Commercial Simvastatin 80mg Alone, in Healthy Subjects
BRL 049653/339 I A Study to Investigate the Mechanism of Fluid Retention with AVANDIA™ in Combination with a Euglycaemic/Hyperinsulinaemic Clamp.
BRL-049653/299 I A single dose study to assess the tolerability and food effect of an enterically-coated formulation of the commercial immediate release tablet of rosiglitazone and an enterically-coated modified release tablet formulation of rosiglitazone in healthy volunteers.
BRL-049653/309 I A study to evaluate the pharmacokinetics of eight prototype formulations of rosiglitazone 8 mg in healthy volunteers.
BRL-049653/413 I A study to evaluate the effect of repeat doses of rosiglitazone on the pharmacokinetics of repeat doses of acitretin in patients receiving acitretin for psoriasis.
BRL49653/301 I A Study to Evaluate the Effect of Food on the Pharmacokinetics of a Modified Release Formulation of Rosiglitazone 8 mg in Healthy Volunteers After Repeat Dosing.
BRL-49653/398 I A study to evaluate the pharmacokinetics of six prototype formulations of rosiglitazone 8 mg in healthy volunteers after repeat dosing.
BRL-49653/903 I A randomized, open-label, two-period crossover study to demonstrate the bioequivalence of twice-daily immediate release and once-daily extended release rosiglitazone dosing over five days in healthy volunteers.
BRL-49653-033 I Placebo controlled, double-blind, trial to study the effect of 12 week treatment with BRL-49653C on glucose and insulin metabolism in obese patients with NIDDM
BRL49653C/117 I A Study to Evaluate the Relative Bioavailability of Two Enterically-Coated Formulations of Rosiglitazone Compared to the Immediate Release Formulation of Rosiglitazone in Healthy Volunteers.
BRL49653C/300 I A Bioequivalence Study Comparing Tablets Manufactured with the 8 mg Anhydrate Form IV (ANF4) to the Commercial Anhydrate Form I (ANF1) of Rosiglitazone Maleate.
DPB102761 I An Open-Label, Randomized Study with 3 Cohorts of 3-Way Crossovers to Investigate the Safety, Tolerability and Pharmacokinetics of XXmg Oral Doses of Investigational Drug and 500mg BID Oral Doses of Metformin (Cohort 1), 8mg Oral Doses of Rosiglitazone (Cohort 2), and 45mg Oral Doses of Pioglitazone (Cohort 3)
RES104033 I A 28-day, Randomised, Double-Blind, Active Comparator, Controlled Study to Assess the Effects of Rosiglitazone, Inhaled Corticosteroid, Theophylline and Theophylline Plus Inhaled Corticosteroid on Inflammation and Pulmonary Function in Asthmatic Smokers.
RES104385 I 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.
RES11098 I A Randomized, Single-Blind, Placebo-Controlled, Parallel Group, Exploratory Research Study to Describe the Pharmacodynamic Effects of Glyburide, Metformin, and Rosiglitazone versus Placebo for 8 Weeks in Adult Subjects with Type 2 Diabetes Mellitus
SB462795_007 I A Two-Period, Randomized, Open-Label, Parallel group, Multiple-Probe Drug Interaction Study to Determine the Effects of NCE on the metabolism of CYP450 Probe Substrates in Healthy Postmenopausal Female Subjects
SB-49653/411 I A Study to Evaluate the Effect of Single and Repeat Doses of Rosiglitazone on the Pharmacokinetics of Methotrexate in Patients Receiving Methotrexate for Psoriasis
SB-712753/001 I A Bioequivalence Study with a Combination Tablet Formulation of Rosiglitazone and Metformin (4 mg/1000 mg) Compared to the Commercial Tablet Formulation of AVANDAMET* (2 mg rosiglitazone/500 mg metformin) and a Dose Proportionality Study Comparing the Combination Tablet Formulations of Rosiglitazone and Metformin (4 mg/1000 mg & 2 mg/1000 mg).
SB-712753/011 I A study to assess the effect of food and time of dosing on the pharmacokinetics of Avandamet™ (rosiglitazone maleate 8 mg/metformin HCl 1000 mg administered as 2 ´ 4/500) Glucophage XR 1000 mg (given as metformin HCl 2 ´ 500 mg) and Avandia™ (rosiglitazone maleate 8 mg) in healthy adult subjects.
SB-712753/012 I A study to estimate the pharmacokinetics of six extended release formulations of AVANDAMET (rosiglitazone maleate 4 mg / metformin HCl 1000 mg), compared to the commercial formulation of AVANDAMET (rosiglitazone maleate 2 mg / metformin HCl 500 mg, q12h), and concomitant dosing of Glucophage XR (metformin HCl 2 ´ 500 mg) with AVANDIA (rosiglitazone maleate 4 mg).
SB-712753/014 I A study to assess the steady state pharmacokinetics of repeat oral doses of AVANDAMET XR (combination formulation of rosiglitazone 8mg/metformin 1000mg) and AVANDAMET IR (rosiglitazone 4mg/metformin 500mg) in healthy subjects
SB-797620/002 I A bioequivalence study with a combination tablet formulation of rosiglitazone and glimepiride (4mg/4mg) compared to concomitant dosing of rosiglitazone 4mg and glimepiride 4mg (4mg + 4mg) commercial tablets in healthy subjects
SB-797620/003 I A study to assess the effect of food on pharmacokinetics of an investigational formulation, and to compare the pharmacokinetics of an investigational formulation to concomitant dosing of rosiglitazone 4mg and glimepiride 4mg commercial tablets in the fed state in healthy subjects
SB-797629/003 I A study to assess the effect of food on pharmacokinetics of a rosiglitazone 4 mg and glimepiride 4 mg combination tablet formulation and to compare the pharmacokinetics of rosiglitazone 4 mg and glimepiride 4 mg combination tablet to concomitant dosing of rosiglitazone 4 mg and glimepiride 4 mg commercial tablets in the fed state in healthy subjects.