Lead Investigator: Tamar Oostrom, The Ohio State University
Title of Proposal Research: Heterogenous Effects in Diabetes Mellitus Clinical Trials and Implications for Physician Prescriptions
Vivli Data Request: 7759
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Medications often have different treatment effects for different individuals. For example, a drug might have higher treatment effects for older patients compared to younger patients, or a drug might work less well for patients with additional comorbidities. This project explores how these different treatment effects translate into physician’s prescribing decisions.
By the design of inclusion and exclusion criteria, and by patient selection, clinical trials enroll a subset of the overall population. However, evidence from clinical trials may be applied to broad patient populations. These populations may be healthier or sicker, younger or older, with more or fewer additional health conditions. What can our evidence from clinical trials tell us about optimal treatment decisions in the real world? We will explore heterogenous treatment effects within clinical trials and explore the implications for physicians’ real-world prescribing decisions in the context of medications for diabetes.
This project will (1) document characteristics of clinical trial participants compared with characteristics of the real-world population of patients that are prescribed diabetes medications. We will also (2) explore which types of patients have larger treatment effects than other groups. We will aggregate results from numerous clinical trials to be able to estimate treatment effects for specific subpopulations. Finally, we will (3) explore how well real-world prescribing decisions correspond to clinical trial treatment effects. For example, if a clinical trial finds that a certain drug works very well for younger patients, are more younger patients prescribed the drug in practice?
Our results will contribute to our understanding of how clinical trial results are interpreted and how clinical trials affect physician practice. We intend to publish our results in high-impact journals and present our work at academic conferences and medical institutions.
Requested Studies:
An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin
Data Contributor: Sanofi
Study ID: NCT01596504
Sponsor ID: PDY12625
A 13-week Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose-Response Trial Assessing the Safety, Tolerability and Efficacy of AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
Data Contributor: Sanofi
Study ID: NCT00299871
Sponsor ID: DRI6012
A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin
Data Contributor: Sanofi
Study ID: NCT00975286
Sponsor ID: EFC10781
A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin
Data Contributor: Sanofi
Study ID: NCT01768559
Sponsor ID: EFC12626
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents
Data Contributor: Sanofi
Study ID: NCT00688701
Sponsor ID: EFC6018
A Randomized, Double-Blind, Placebo-Controlled, 2-arm Parallel-group, Multicenter Study With a 24-Week Treatment Period Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Sulfonylurea
Data Contributor: Sanofi
Study ID: NCT00866658
Sponsor ID: EFC10887
A Randomized, Open-label, Active-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 Versus Exenatide on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin
Data Contributor: Sanofi
Study ID: NCT00707031
Sponsor ID: EFC6019
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of a Sulfonylurea in Patients With Type 2 Diabetes Not Adequately Controlled With Sulfonylurea
Data Contributor: Sanofi
Study ID: NCT00713830
Sponsor ID: EFC6015
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 in Two Titration Regimens on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin
Data Contributor: Sanofi
Study ID: NCT00763451
Sponsor ID: EFC10743
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin
Data Contributor: Sanofi
Study ID: NCT00715624
Sponsor ID: EFC6016
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin
Data Contributor: Sanofi
Study ID: NCT00712673
Sponsor ID: EFC6014
A Randomized, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin
Data Contributor: Sanofi
Study ID: NCT00976937
Sponsor ID: EFC10780
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone
Data Contributor: Sanofi
Study ID: NCT00763815
Sponsor ID: EFC6017
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome
Data Contributor: Sanofi
Study ID: NCT01147250
Sponsor ID: EFC11319
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin
Data Contributor: Sanofi
Study ID: NCT01632163
Sponsor ID: EFC12382
An Open-label, Multicenter 24-Week And 52-Week Study Assessing The Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
Data Contributor: Sanofi
Study ID: NCT01960179
Sponsor ID: SFY13476
An Open-Label, Multicenter 52-Week Study Assessing the Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes
Data Contributor: Sanofi
Study ID: NCT01940965
Sponsor ID: LTS12809
Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period
Data Contributor: Sanofi
Study ID: NCT01169779
Sponsor ID: EFC11321
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
Data Contributor: GSK
Study ID: NCT00679939
Sponsor ID: AVD111179
AVANDIA CV Outcomes Study: 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
Data Contributor: GSK
Study ID: NCT00879970
Sponsor ID: 111960
A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)
Data Contributor: GSK
Study ID: NCT00551564
Sponsor ID: DIX110434
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
Data Contributor: GSK
Study ID: NCT00279045
Sponsor ID: 49653/048
A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus
Data Contributor: GSK
Study ID: NCT00500955
Sponsor ID: BRL-49653/137
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
Data Contributor: GSK
Study ID: NCT00379769
Sponsor ID: BRL-049653/231
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
Data Contributor: GSK
Study ID: 49653/325
Sponsor ID: 49653/325
Effect of Rosiglitazone and Placebo on Carotid Intima Media Thickness in Patients With Insulin Resistance Syndrome and/or Type 2 Diabetes
Data Contributor: GSK
Study ID: NCT00306644
Sponsor ID: 49653/334
A Study to Investigate the Mechanism of Fluid Retention with AVANDIA™ in Combination with a Euglycaemic/Hyperinsulinaemic Clamp
Data Contributor: GSK
Study ID: 49653/339
Sponsor ID: 49653/339
A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia
Data Contributor: GSK
Study ID: NCT00306696
Sponsor ID: 49653/342
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
Data Contributor: GSK
Study ID: NCT00329225
Sponsor ID: 49653/347
A 12 month randomized, 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
Data Contributor: GSK
Study ID: 49653/351
Sponsor ID: 49653/351
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
Data Contributor: GSK
Study ID: 49653/352
Sponsor ID: 49653/352
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.
Data Contributor: GSK
Study ID: 49653/414
Sponsor ID: 49653/414
An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosiglitazone when Co-administered with Gemfibrozil in Healthy Adult Subjects
Data Contributor: GSK
Study ID: 49653/902
Sponsor ID: 49653/902
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.
Data Contributor: GSK
Study ID: 49653/903
Sponsor ID: 49653/903
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
Data Contributor: GSK
Study ID: RES11098
Sponsor ID: RES11098
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.
Data Contributor: GSK
Study ID: 49653/009
Sponsor ID: 49653/009
A 26 Week Randomised, Double-Blind, Multicentre Study to Investigate the Effects of Rosiglitazone on Insulin Requirements in Insulin-Treated Type 2 Diabetic Patients
Data Contributor: GSK
Study ID: 49653/085
Sponsor ID: 49653/085
A 3-Year Open-Label, Multicenter, Active (Glyburide) Comparison Study, to Evaluate the Effect of BRL49653C 8mg once daily on Cardiovascular Function in Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM)
Data Contributor: GSK
Study ID: 49653/097
Sponsor ID: 49653/097
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)
Data Contributor: GSK
Study ID: 49653/112
Sponsor ID: 49653/112
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
Data Contributor: GSK
Study ID: 49653/114
Sponsor ID: 49653/114
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)
Data Contributor: GSK
Study ID: BRL-049653/131
Sponsor ID: BRL-049653/131
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.
Data Contributor: GSK
Study ID: 49653/025
Sponsor ID: 49653/025
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
Data Contributor: GSK
Study ID: NCT00499707
Sponsor ID: 712753/007
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
Data Contributor: GSK
Study ID: 712753/002
Sponsor ID: 712753/002
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
Data Contributor: GSK
Study ID: 712753/003
Sponsor ID: 712753/003
A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET® (8.0mg / 2.0g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy
Data Contributor: GSK
Study ID: NCT00069836
Sponsor ID: 712753/009
A 24-week Randomized, Double-blind, Double-Dummy, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of Avandia™ XR and AVANDIA™ (4mg BD) in Patients with Type 2 Diabetes
Data Contributor: GSK
Study ID: 49653/183
Sponsor ID: 49653/183
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
Data Contributor: GSK
Study ID: AXR100723
Sponsor ID: AXR100723
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
Data Contributor: GSK
Study ID: 49653/135
Sponsor ID: 49653/135
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).
Data Contributor: GSK
Study ID: 49653/136
Sponsor ID: 49653/136
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Effects of Rosiglitazone on Post Prandial Glycaemia in Type 2 Diabetic Patients.
Data Contributor: GSK
Study ID: 49653/140
Sponsor ID: 49653/140
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
Data Contributor: GSK
Study ID: NCT00333723
Sponsor ID: 49653/143
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
Data Contributor: GSK
Study ID: NCT00501020
Sponsor ID: 49653/284
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
Data Contributor: GSK
Study ID: NCT00044460
Sponsor ID: 49653/326
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
Data Contributor: GSK
Study ID: BRL-049653/282
Sponsor ID: BRL-049653/282
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.
Data Contributor: GSK
Study ID: NCT00197132
Sponsor ID: 49653/375
A Bioequivalence Study with a Combination Tablet Formulation of Rosiglitazone and Metformin (4mg/1000mg) Compared to the Commercial Tablet Formulation of AVANDAMET (2mg rosiglitazone/500mg metformin) and a Dose Proportionality Study Comparing the Combination Tablet Formulations of Rosiglitazone and Metformin (4mg/1000mg & 2mg/1000mg).
Data Contributor: GSK
Study ID: SB-712753/001
Sponsor ID: SB-712753/001
A study to estimate the pharmacokinetics of six extended release formulations of AVANDAMET (rosiglitazone maleate 4mg / metformin HCl 1000mg), compared to the commercial formulation of AVANDAMET (rosiglitazone maleate 2mg / metformin HCl 500mg, q12h), and concomitant dosing of Glucophage XR (metformin HCl 2 × 500mg) with AVANDIA (rosiglitazone maleate 4mg)
Data Contributor: GSK
Study ID: SB-712753/012
Sponsor ID: SB-712753/012
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
Data Contributor: GSK
Study ID: 049653/109
Sponsor ID: 049653/109
A Double-Blind Study to Assess the Effect of Rosiglitazone (RSG) on the Pharmacodynamics and Pharmacokinetics of Acenocoumerol in Healthy Male Volunteers
Data Contributor: GSK
Study ID: 49653/225
Sponsor ID: 49653/225
A Study to Estimate the Effect of Repeat Oral Doses of Rosiglitazone (8mg) on the Pharmacokinetics of Glimepiride (4mg) and the Effect of a Single Oral Dose of Glimepiride (4mg) on the Pharmacokinetics of Rosiglitazone (8mg) in Healthy Subjects.
Data Contributor: GSK
Study ID: 49653/340
Sponsor ID: 49653/340
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
Data Contributor: GSK
Study ID: 49653/207
Sponsor ID: 49653/207
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.
Data Contributor: GSK
Study ID: BRL-049653/299
Sponsor ID: BRL-049653/299
A study to evaluate the pharmacokinetics of eight prototype formulations of rosiglitazone 8mg in healthy volunteers.
Data Contributor: GSK
Study ID: BRL-049653/309
Sponsor ID: BRL-049653/309
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
Data Contributor: GSK
Study ID: BRL-049653/369
Sponsor ID: BRL-049653/369
A Study to Evaluate the Effect of Food on the Pharmacokinetics of a Modified Release Formulation of Rosiglitazone 8mg in Healthy Volunteers After Repeat Dosing.
Data Contributor: GSK
Study ID: BRL49653/301
Sponsor ID: BRL49653/301
A Bioequivalence Study Comparing Tablets Manufactured with the 8mg Anhydrate Form IV (ANF4) to the Commercial Anhydrate Form I (ANF1) of Rosiglitazone Maleate.
Data Contributor: GSK
Study ID: BRL49653C/300
Sponsor ID: BRL49653C/300
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
Data Contributor: GSK
Study ID: BRL-049653/311
Sponsor ID: BRL-049653/311
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.
Data Contributor: GSK
Study ID: 49653/015
Sponsor ID: 49653/015
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.
Data Contributor: GSK
Study ID: 49653/020
Sponsor ID: 49653/020
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.
Data Contributor: GSK
Study ID: 49653/079
Sponsor ID: 49653/079
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
Data Contributor: GSK
Study ID: 49653/096
Sponsor ID: 49653/096
A 26-Week Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of BRL49653C when Administered Twice Daily to Patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM) who are Inadequately Controlled on Insulin Monotherapy
Data Contributor: GSK
Study ID: 49653/082
Sponsor ID: 49653/082
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
Data Contributor: GSK
Study ID: 49653/095
Sponsor ID: 49653/095
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.
Data Contributor: GSK
Study ID: 712753/011
Sponsor ID: 712753/011
A 28-Week, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Extended Release AVANDAMET in Subjects with Type 2 Diabetes Mellitus
Data Contributor: GSK
Study ID: AVM100344
Sponsor ID: AVM100344
A Randomized, Parallel Group, Double-blind, Multi-center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment.
Data Contributor: GSK
Study ID: NCT00386100
Sponsor ID: AVT105913
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
Data Contributor: GSK
Study ID: NCT00067951
Sponsor ID: 712753/004
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
Data Contributor: GSK
Study ID: 712753/014
Sponsor ID: 712753/014