Rosiglitazone has been evaluated in numerous Phase 1 through Phase 4 clinical trials, including drug interaction studies and assessments in healthy volunteers. These trials investigate conditions ranging from metabolic disorders, Alzheimer's disease, hepatitis C, cystic fibrosis, and erectile dysfunction to neoplasms like non-small cell lung cancer, thyroid cancer, and renal cell carcinoma. Sponsored by both academic institutions and pharmaceutical companies, overall trial statuses include completed, active, recruiting, terminated, suspended, and withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04114136 | RECRUITING | Melanoma; NSCLC; Hepatocellular Carcinoma; Urothelial Cancer; Gastric Adenocarcinoma; HNSCC; Esophageal Adenocarcinoma; Microsatellite Instability-High Solid Malignant Tumor |
Dan Zandberg |
2020-09-14 | PHASE2 |
| NCT01019356 | COMPLETED | Polycystic Ovary Syndrome |
Jean-Patrice Baillargeon |
2006-08 | |
| NCT02694874 | COMPLETED | Malaria |
Centro de Investigacao em Saude de Manhica |
2016-02 | |
| NCT03309319 | UNKNOWN | Pituitary Tumor |
Zhaoyun Zhang |
2016-10-16 | |
| NCT01287598 | COMPLETED | Neoplasms |
Bayer |
2011-08-02 | PHASE1 |
| NCT02737709 | Terminated | Non-small Cell Lung Cancer |
Sun Yat-sen University |
2016-03 | Phase 2 |
| NCT00640224 | COMPLETED | Polycystic Ovary Syndrome |
Silva Arslanian |
2005-03 | PHASE4 |
| NCT01174056 | COMPLETED | Lung Inflammation |
Washington University School of Medicine |
2011-07 | EARLY_PHASE1 |
| NCT00240604 | UNKNOWN | Glucose Intolerance |
Hadassah Medical Organization |
2005-04 | PHASE3 |
| NCT00933309 | COMPLETED | Breast Cancer |
M.D. Anderson Cancer Center |
2009-07 | PHASE1 |
| NCT00577590 | COMPLETED | Diabetes Mellitus, Type II |
Washington University School of Medicine |
2003-10 | |
| NCT01100619 | COMPLETED | Papillary Thyroid Cancer; Follicular Thyroid Cancer; Huerthle Cell Thyroid Cancer; Renal Cell Carcinoma |
Exelixis |
2010-04 | PHASE1 |
| NCT00607945 | COMPLETED | Type 2 Diabetes Mellitus |
Ohio State University |
2008-01 | PHASE1 |
| NCT00953498 | COMPLETED | Type 2 Diabetes |
Centre Hospitalier Universitaire Dijon |
2007-10 | PHASE4 |
| NCT01209143 | COMPLETED | Solid Cancers |
Genentech, Inc. |
2010-11 | PHASE1 |
| NCT00242593 | UNKNOWN | Mild Cognitive Impairment |
University of Washington |
2006-06 | PHASE2 |
| NCT00964106 | COMPLETED | Drug Interactions |
GlaxoSmithKline |
2009-08-26 | PHASE1 |
| NCT01402076 | Completed | Healthy Volunteers |
Vanda Pharmaceuticals |
2011-08 | Phase 1 |
| NCT01402076 | COMPLETED | Healthy Volunteers |
Vanda Pharmaceuticals |
2011-08 | PHASE1 |
| NCT00831129 | COMPLETED | Pre-diabetes |
University of Chicago |
2006-09 | PHASE2; PHASE3 |
| NCT00081328 | COMPLETED | Diabetes Mellitus, Type II |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2004-05 | PHASE3 |
| NCT00337350 | COMPLETED | Schizophrenia |
Massachusetts General Hospital |
2003-09 | PHASE4 |
| NCT00618072 | COMPLETED | Hyperinsulinemia; Insulin Resistance; Obesity |
New York Medical College |
2008-01 | PHASE2 |
| NCT01406704 | TERMINATED | NASH (Non-alcoholic Steato-hepatitis) |
Seoul St. Mary's Hospital |
2004-01 | PHASE4 |
| NCT00612066 | TERMINATED | Cushing's Disease |
Jonsson Comprehensive Cancer Center |
2007-04 | PHASE2 |
| NCT00616642 | TERMINATED | Brain and Central Nervous System Tumors |
Jonsson Comprehensive Cancer Center |
2006-10 | PHASE2 |
| NCT00879970 | TERMINATED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2009-05 | PHASE4 |
| NCT01453049 | TERMINATED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2010-04 | PHASE3 |
| NCT00679939 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2008-04-21 | PHASE4 |
| NCT00252499 | TERMINATED | Fatty Liver; Insulin Resistance |
US Department of Veterans Affairs |
2005-10 | |
| NCT01574820 | COMPLETED | Prediabetes; Coronary Artery Disease; Insulin Resistance; Glucose Intolerance |
National Cheng-Kung University Hospital |
2006-11 | PHASE3 |
| NCT00130286 | COMPLETED | HIV-Associated Lipodystrophy Syndrome; Insulin Resistance; HIV Infections; Metabolic Syndrome X; Body Weight Changes |
Weill Medical College of Cornell University |
2005-03 | PHASE1; PHASE2 |
| NCT01017666 | COMPLETED | Healthy |
Biogen |
2009-11-01 | PHASE1 |
| NCT00098852 | UNKNOWN | Head and Neck Cancer |
University of California, San Francisco |
2004-10 | PHASE2 |
| NCT00819910 | TERMINATED | Hypertriglyceridemia in Type 4 Hyperlipidemia; Non Diabetic Subjects With Normoglycemia |
Ahmad Slim |
2008-09 | PHASE4 |
| NCT01376063 | COMPLETED | Healthy Adult Subjects |
Kyntra Bio |
2010-03 | PHASE1 |
| NCT01415128 | COMPLETED | Erectile Dysfunction |
VIVUS LLC |
2010-04 | PHASE1 |
| NCT01100619 | Completed | Papillary Thyroid Cancer|Follicular Thyroid Cancer|Huerthle Cell Thyroid Cancer|Renal Cell Carcinoma |
Exelixis |
2010-04 | Phase 1 |
| NCT01415128 | Completed | Erectile Dysfunction |
VIVUS LLC |
2010-04 | Phase 1 |
| NCT01150981 | COMPLETED | Metabolic Syndrome; Insulin Resistance |
University of Massachusetts, Worcester |
2006-11 | PHASE2 |
| NCT01376063 | Completed | Healthy Adult Subjects |
FibroGen |
2010-03 | Phase 1 |
| NCT01060566 | COMPLETED | Cystic Fibrosis |
Vertex Pharmaceuticals Incorporated |
2010-02 | PHASE1 |
| NCT01088594 | COMPLETED | Type 2 Diabetes Mellitus |
Solvay Pharmaceuticals |
2010-02 | PHASE1 |
| NCT00614874 | COMPLETED | Asthma |
Creighton University |
2008-12 | PHASE2 |
| NCT00116922 | COMPLETED | Impaired Glucose Tolerance; Diabetes |
Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
2004-06 | PHASE3 |
| NCT00207402 | COMPLETED | Hepatitis C |
Brooke Army Medical Center |
2005-10 | PHASE4 |
| NCT01332071 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2009-11-24 | PHASE1 |
| NCT00242619 | COMPLETED | Depression; Bipolar Disorder; Insulin Resistance |
Stanford University |
2007-07 | |
| NCT00738023 | COMPLETED | Type 2 Diabetes; Hypertension |
Emory University |
2004-03 | PHASE4 |
| NCT00143624 | COMPLETED | Atherosclerosis; HIV Infections |
University of British Columbia |
2003-06 | |
| NCT00680745 | COMPLETED | Type 2 Diabetes |
AstraZeneca |
2008-04 | PHASE3 |
| NCT00609362 | COMPLETED | Change in Bone Mineral Density; Change in Bone Marrow Fat Content |
University of Aarhus |
2008-01 | PHASE2 |
| NCT00884533 | WITHDRAWN | Alzheimer's Disease |
GlaxoSmithKline |
2009-06 | PHASE1 |
| NCT00699036 | UNKNOWN | Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease |
Brooke Army Medical Center |
2007-04 | PHASE2 |
| NCT00490568 | TERMINATED | Alzheimer's Disease |
GlaxoSmithKline |
2007-08-08 | PHASE3 |
| NCT00486187 | COMPLETED | Type 2 Diabetes Mellitus |
Dr. Milan Gupta |
2006-04 | |
| NCT00811356 | TERMINATED | Malaria |
GlaxoSmithKline |
2008-12-11 | PHASE1 |
| NCT00348140 | COMPLETED | Alzheimer's Disease |
GlaxoSmithKline |
2006-07-12 | PHASE3 |
| NCT00550420 | TERMINATED | Alzheimer's Disease |
GlaxoSmithKline |
2007-10-01 | PHASE3 |
| NCT00381238 | COMPLETED | Alzheimer's Disease |
GlaxoSmithKline |
2006-06-20 | PHASE2 |
| NCT01872780 | COMPLETED | Healthy |
Inje University |
2008-08 | PHASE1 |
| NCT00348309 | COMPLETED | Alzheimer's Disease |
GlaxoSmithKline |
2006-07-06 | |
| NCT00437970 | WITHDRAWN | Diabetes Mellitus, Type 2 |
Menzies School of Health Research |
2008-04 | PHASE4 |
| NCT00733174 | UNKNOWN | Impaired Glucose Tolerance |
Denver Research Institute |
2004-03 | PHASE4 |
| NCT00367744 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2006-07 | PHASE2 |
| NCT00324675 | COMPLETED | Type 2 Diabetes; Overt Diabetic Nephropathy |
Technische Universität Dresden |
2006-08 | |
| NCT00379769 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2001-04 | PHASE3 |
| NCT00733785 | COMPLETED | Alzheimer's Disease |
GlaxoSmithKline |
2008-08-13 | PHASE1 |
| NCT00166803 | SUSPENDED | Diabetes Mellitus, Atherosclerosis |
National Taiwan University Hospital |
2005-06 | |
| NCT00367055 | COMPLETED | Type 2 Diabetes Mellitus |
GlaxoSmithKline |
2004-10 | PHASE4 |
| NCT00370305 | COMPLETED | Metabolic Syndrome; Impaired Glucose Tolerance |
Charite University, Berlin, Germany |
2004-05 | PHASE2 |
| NCT00785213 | COMPLETED | Healthy |
Mutual Pharmaceutical Company, Inc. |
2008-09 | PHASE1 |
| NCT00551564 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2007-07-31 | PHASE1 |
| NCT00428090 | COMPLETED | Alzheimer's Disease |
GlaxoSmithKline |
2007-02-27 | PHASE3 |
| NCT00688207 | COMPLETED | Alzheimer's Disease |
GlaxoSmithKline |
2008-04 | PHASE1 |
| NCT00186537 | COMPLETED | Insulin Resistance; Hypertriglyceridemia |
Stanford University |
2003-09 | |
| NCT00194896 | COMPLETED | Type 2 Diabetes Mellitus |
University of Washington |
2000-02 | |
| NCT00413335 | COMPLETED | Obesity; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus |
Yale University |
2005-11 | |
| NCT00692510 | COMPLETED | Metabolism; Alzheimer's Disease |
AstraZeneca |
2007-11 | PHASE1 |
| NCT00116831 | COMPLETED | Atherosclerosis |
GlaxoSmithKline |
2005-01 | PHASE3 |
| NCT00265148 | COMPLETED | Alzheimer's Disease |
GlaxoSmithKline |
2004-05-18 | PHASE2 |
| NCT00135330 | COMPLETED | Diabetes Mellitus, Type 2 |
AstraZeneca |
2005-10 | PHASE3 |
| NCT00405015 | COMPLETED | Ischemia-Reperfusion Injury; The Metabolic Syndrome |
Radboud University Medical Center |
2007-04 | PHASE2 |
| NCT00032487 | COMPLETED | Type 2 Diabetes Mellitus |
VA Office of Research and Development |
2000-12-01 | PHASE3 |
| NCT00121953 | WITHDRAWN | Endometriosis |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2005-07 | PHASE2; PHASE3 |
| NCT00484419 | COMPLETED | Type 2 Diabetes; Hyperlipidemia |
Daiichi Sankyo |
2007-05 | PHASE3 |
| NCT00427154 | TERMINATED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2007-01-10 | PHASE3 |
| NCT00343980 | TERMINATED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-10-10 | PHASE3 |
| NCT00348712 | TERMINATED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-10-30 | PHASE3 |
| NCT00567593 | COMPLETED | Inflammatory Bowel Disease |
James Lewis |
2007-10 | PHASE4 |
| NCT00452166 | TERMINATED | Chronic Kidney Disease; Insulin Resistance |
Leiden University Medical Center |
2007-04 | PHASE3 |
| NCT00615212 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2008-01-02 | PHASE1 |
| NCT00065065 | COMPLETED | Ulcerative Colitis; Inflammatory Bowel Disease |
James Lewis |
2002-09 | PHASE2 |
| NCT00636766 | COMPLETED | Carotid Atherosclerosis; Stroke; Type 2 Diabetes; Metabolic Syndrome |
Aristotle University Of Thessaloniki |
2005-09 | |
| NCT00466713 | TERMINATED | Dilated Cardiomyopathy |
Stanford University |
2007-03 | |
| NCT00361868 | TERMINATED | Dyslipidemia; Glucose Metabolism Disorder |
Solvay Pharmaceuticals |
2006-06 | PHASE3 |
| NCT00343395 | TERMINATED | Coronary Artery Disease |
Intermountain Health Care, Inc. |
2006-06 | PHASE4 |
| NCT00399711 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-11 | PHASE3 |
| NCT00318656 | COMPLETED | Non-Insulin-Dependent Diabetes Mellitus |
GlaxoSmithKline |
2005-11 | PHASE4 |
| NCT00295633 | COMPLETED | Diabetes Mellitus, Type 2 |
AstraZeneca |
2006-03 | PHASE3 |
| NCT00350779 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2006-06-12 | PHASE3 |
| NCT00511823 | COMPLETED | Nausea and Vomiting, Chemotherapy-Induced |
GlaxoSmithKline |
2007-07-23 | PHASE1 |
| NCT00402909 | COMPLETED | Type 2 Diabetes |
Novartis Pharmaceuticals |
2006-11 | PHASE4 |
| NCT00333151 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-05 | PHASE3 |
| NCT00369174 | COMPLETED | Oral Leukoplakia |
National Cancer Institute (NCI) |
2006-06 | PHASE2 |
| NCT00571506 | COMPLETED | Diabetes Mellitus, Type 2; Vascular Diseases |
University of Arkansas |
2004-05 | PHASE4 |
| NCT00121966 | COMPLETED | Type 2 Diabetes Mellitus |
Odense University Hospital |
2003-01 | PHASE4 |
| NCT00169832 | COMPLETED | Diabetes; Coronary Artery Bypass Grafting |
Laval University |
2003-06 | PHASE3 |
| NCT00465296 | TERMINATED | Metabolic Syndrome |
Medstar Health Research Institute |
2006-01 | PHASE3 |
| NCT00334568 | TERMINATED | Alzheimer's Disease |
GlaxoSmithKline |
2004-12 | PHASE2 |
| NCT00297063 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2006-01-11 | PHASE3 |
| NCT00468897 | COMPLETED | Alzheimer's Disease |
GlaxoSmithKline |
2007-03-21 | PHASE1 |
| NCT01577095 | COMPLETED | Type 2 Diabetes Mellitus With Features of Insulin Resistance |
China Medical University Hospital |
2006-04 | PHASE2 |
| NCT00318422 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-05 | PHASE3 |
| NCT00138619 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-11 | PHASE3 |
| NCT00424762 | COMPLETED | Diabetes Mellitus, Type 2 |
University of Texas Southwestern Medical Center |
2005-02 | PHASE4 |
| NCT00432679 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2006-05-24 | PHASE3 |
| NCT00541775 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2006-06 | PHASE3 |
| NCT00746174 | COMPLETED | Insulin Sensitivity |
University of Texas Southwestern Medical Center |
2004-02 | PHASE4 |
| NCT00178841 | COMPLETED | Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome |
Vanderbilt University |
2005-06 | PHASE2 |
| NCT00675740 | COMPLETED | Impaired Glucose Tolerance |
University of Leipzig |
2004-01 | PHASE4 |
| NCT00373178 | COMPLETED | Type 2 Diabetes Mellitus |
Aristotle University Of Thessaloniki |
2005-01 | PHASE4 |
| NCT00379600 | COMPLETED | Arthritis, Rheumatoid |
GlaxoSmithKline |
2004-11 | PHASE2 |
| NCT00362726 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2006-09 | PHASE1 |
| NCT00285805 | COMPLETED | Insulin Resistance |
Radboud University Medical Center |
2006-02 | |
| NCT00364221 | COMPLETED | Metabolic Syndrome; Insulin Resistance |
University of Colorado, Denver |
2004-11 | PHASE4 |
| NCT00318630 | COMPLETED | Asthma |
GlaxoSmithKline |
2005-07-22 | PHASE1 |
| NCT00279045 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2000-01-03 | PHASE3 |
| NCT00115661 | TERMINATED | Endometriosis |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2005-07 | PHASE2 |
| NCT00084578 | WITHDRAWN | Bladder Cancer |
Fox Chase Cancer Center |
2004-03 | |
| NCT00004180 | COMPLETED | Sarcoma |
Dana-Farber Cancer Institute |
1999-10 | PHASE2 |
| NCT01045590 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2003-12 | PHASE4 |
| NCT00015691 | COMPLETED | HIV Infections; Lipodystrophy; Hyperinsulinemia |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00241605 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2003-06-25 | PHASE4 |
| NCT00123643 | COMPLETED | Type 2 Diabetes Mellitus |
St. Paul Heart Clinic |
2003-05 | PHASE4 |
| NCT00149383 | COMPLETED | Falciparum Malaria |
Mahidol University |
2004-12 | PHASE1; PHASE2 |
| NCT00422955 | COMPLETED | Neuropathy, Diabetic |
GlaxoSmithKline |
2003-11 | PHASE3 |
| NCT00225225 | TERMINATED | Diabetes Mellitus, Type 2 |
Stanford University |
2002-10 | |
| NCT00099918 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-05 | PHASE3 |
| NCT00231387 | COMPLETED | Non-insulin-dependent Diabetes Mellitus |
GlaxoSmithKline |
2002-09 | PHASE3 |
| NCT04148183 | COMPLETED | Insulin Resistance |
J JESUS VENEGAS, MD |
2004-01-01 | PHASE2; PHASE3 |
| NCT00499707 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2003-10-08 | PHASE3 |
| NCT00067951 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2003-10-17 | PHASE3 |
| NCT00069836 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2003-10 | PHASE3 |
| NCT00306644 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2002-05 | PHASE4 |
| NCT00672919 | COMPLETED | Diabetes Mellitus |
Takeda |
2003-11 | PHASE4 |
| NCT00329225 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2002-09 | PHASE4 |
| NCT00331487 | COMPLETED | Diabetes Mellitus |
Takeda |
2000-09 | PHASE3 |
| NCT00182052 | COMPLETED | Adenocarcinoma of the Prostate; Prostate Cancer |
Massachusetts General Hospital |
2000-09 | PHASE3 |
| NCT00197132 | COMPLETED | Insulin Resistance |
GlaxoSmithKline |
2002-10 | PHASE3 |
| NCT00044460 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2002-05 | PHASE4 |
| NCT00501020 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2001-06-05 | PHASE4 |
| NCT00333723 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2000-07-28 | PHASE4 |
| NCT02526615 | COMPLETED | Insulin Sensitivity; Type 2 Diabetes |
Turku University Hospital |
2000-10 | PHASE4 |
| NCT00304993 | COMPLETED | Metabolic Syndrome X; Insulin Resistance |
Foundation Research, Florida |
2001-01 | PHASE4 |
| NCT00140647 | COMPLETED | Atherosclerosis; Impaired Glucose Tolerance; Isolated Impaired Fasting Glucose; Cardiovascular Disease |
Gerstein, Hertzel, MD |
2001-07 | PHASE3 |
| NCT00358124 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2001-01 | PHASE4 |
| NCT00309660 | UNKNOWN | Ulcerative Colitis |
Herlev Hospital |
2005-11 | PHASE1; PHASE2 |
| NCT00225355 | TERMINATED | Angina Pectoris; Metabolic Syndrome X |
University of Glasgow |
2006-02 | PHASE4 |
| NCT00290394 | COMPLETED | Diabetes Mellitus, Type 2 |
Baskent University |
2004-03 | PHASE4 |
| NCT00492700 | COMPLETED | Non Alcoholic Steatohepatitis |
Association pour la Recherche sur les Maladies Hépatiques Virales |
2003-01 | PHASE2 |
| NCT00193648 | COMPLETED | Focal Glomerulosclerosis |
Northwell Health |
2005-07 | PHASE1 |
| NCT00274495 | TERMINATED | Chronic Hepatitis C Infection; Fatty Liver |
Beth Israel Medical Center |
2006-01 | PHASE4 |
| NCT00018382 | COMPLETED | Alzheimer Disease |
US Department of Veterans Affairs |
1999-10 | PHASE2 |
| NCT00094796 | COMPLETED | Diabetes Mellitus, Type II; Insulin Resistance |
National Heart, Lung, and Blood Institute (NHLBI) |
2004-10-20 | PHASE2 |
| NCT00516880 | UNKNOWN | Chronic Disease; Kidney Diseases; Cardiovascular Diseases |
Hospital Authority, Hong Kong |
2006-03 | |
| NCT00110851 | COMPLETED | Type 2 Diabetes Mellitus |
Wellstat Therapeutics |
2005-04 | PHASE2 |
| NCT00025753 | COMPLETED | HIV Infections; Insulin Resistance |
National Center for Research Resources (NCRR) |
||
| NCT00443170 | COMPLETED | Healthy Subjects; Anaemia |
GlaxoSmithKline |
2006-11 | PHASE1 |
| NCT00123227 | UNKNOWN | Diabetes Mellitus, Type 2; Vascular Diseases; Hypertension |
Royal Brompton & Harefield NHS Foundation Trust |
2002-10 | PHASE3 |
| NCT00225342 | WITHDRAWN | Angina Pectoris; Diabetes Mellitus, Type 2 |
University of Glasgow |
PHASE4 | |
| NCT00440375 | COMPLETED | Type 2 Diabetes Mellitus; Obesity; Menopause |
Baskent University |
2005-06 | PHASE4 |
| NCT00039663 | COMPLETED | HIV Infections |
National Institutes of Health Clinical Center (CC) |
2002-05 | PHASE1 |
| NCT00095654 | COMPLETED | Impaired Glucose Tolerance; Cardiovascular Disease; Glucose Metabolism Disorders |
Gerstein, Hertzel, MD |
2001-07 | PHASE3 |
| NCT00150410 | COMPLETED | Diabetes Mellitus |
Pfizer |
2003-01 | PHASE3 |
| NCT00409097 | UNKNOWN | Critical Illness; Multiple Organ Failure |
Amsterdam UMC, location VUmc |
2006-04 | PHASE3 |
| NCT00483392 | COMPLETED | Insulin Resistance |
University Medical Centre Ljubljana |
||
| NCT00549874 | COMPLETED | Type 2 Diabetes |
University of Michigan |
2002-02 | |
| NCT00203632 | TERMINATED | Diabetes Mellitus |
University of Calgary |
2003-09 | PHASE3 |
| NCT00064727 | COMPLETED | Congestive Heart Failure |
National Heart, Lung, and Blood Institute (NHLBI) |
2003-07-09 | PHASE2 |
| NCT00372086 | COMPLETED | Type 1 Diabetes; Puberty: >Tanner 2 Breast Development or Testis >4ml |
The University of New South Wales |
2003-08 | PHASE4 |
| NCT00349427 | COMPLETED | Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2005-10 | PHASE3 |
| NCT00522470 | COMPLETED | Type 2 Diabetes Mellitus; Obesity |
Baskent University |
PHASE4 | |
| NCT00500955 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2000-04 | PHASE3 |
| NCT00169923 | WITHDRAWN | Chronic Kidney Disease; Inflammation |
Leiden University Medical Center |
2007-04 | PHASE2; PHASE3 |
| NCT00015626 | COMPLETED | Insulin Resistance; Diabetes Mellitus |
National Center for Research Resources (NCRR) |
PHASE2 | |
| NCT00300911 | COMPLETED | Diabetes Mellitus, Type 2 |
Baskent University |
2005-12 | PHASE4 |
| NCT00154011 | COMPLETED | Healthy Subjects |
Technische Universität Dresden |
2005-09 | |
| NCT00523913 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2005-11 | PHASE3 |
| NCT00264251 | COMPLETED | HIV Infections; Insulin Resistance; Obesity |
St. Luke's-Roosevelt Hospital Center |
2005-07 | |
| NCT00549263 | WITHDRAWN | Healthy Subjects |
GlaxoSmithKline |
2008-02 | PHASE1 |
| NCT00306696 | COMPLETED | Diabetes Mellitus |
GlaxoSmithKline |
2002-10 | PHASE4 |
| NCT00116792 | UNKNOWN | Coronary Artery Disease; Diabetes Mellitus |
Gold, Herman K., MD |
2004-03 | PHASE2; PHASE3 |
| NCT00314561 | COMPLETED | Metabolic Syndrome |
Korea University Anam Hospital |
2006-05 | PHASE4 |
| NCT00309309 | COMPLETED | Kidney Transplant |
Mario Negri Institute for Pharmacological Research |
2005-04 | PHASE2 |
| NCT00282945 | TERMINATED | Type 2 Diabetes Mellitus |
Pfizer |
2006-01 | |
| NCT00306176 | COMPLETED | Type II Diabetes Mellitus |
Aristotle University Of Thessaloniki |
2005-01 | PHASE4 |
| NCT00006493 | COMPLETED | HIV Infections; Hyperlipidemia |
National Center for Research Resources (NCRR) |
PHASE2 | |
| NCT00489229 | COMPLETED | Diabetes; Impaired Glucose Tolerance |
Universiti Sains Malaysia |
2002-10 | PHASE3 |
| NCT00285142 | COMPLETED | Healthy |
University Hospital, Montpellier |
2004-06 | |
| NCT00232362 | WITHDRAWN | Type 2 Diabetes Mellitus |
Texas Tech University Health Sciences Center |
2007-06 | PHASE1 |
| NCT00119496 | COMPLETED | Asthma |
University of Glasgow |
2005-07 | PHASE2; PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-06-23)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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