Numerous clinical trials spanning Phase 1 to Phase 4 evaluate glimepiride across healthy volunteers and populations with Type 2 diabetes mellitus, cardiovascular diseases, congestive heart failure, and chronic kidney failure. Sponsored by academic centers, pharmaceutical companies, and government institutes, these studies encompass completed, terminated, withdrawn, and unknown recruitment statuses. Altogether, this research landscape highlights the extensive clinical investigation of glimepiride in managing metabolic and cardiovascular pathologies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07288749 | NOT_YET_RECRUITING | Type 2 Diabetes Mellitus (T2DM); Chronic Heart Failure (CHF) |
Tongji Hospital |
2026-01-01 | PHASE3 |
| NCT07589387 | NOT_YET_RECRUITING | Diabete Mellitus |
Washington University School of Medicine |
2026-05-01 | |
| NCT07365358 | NOT_YET_RECRUITING | Diabete Type 2 |
Chong Kun Dang Pharmaceutical |
2026-03 | PHASE4 |
| NCT05975528 | UNKNOWN | Diabetes Mellitus; Cellular Senescence; Sodium-Glucose Transporter 2 Inhibitors |
Yonsei University |
2023-06-01 | PHASE4 |
| NCT06759922 | COMPLETED | Type 2 Diabetes Mellitus |
Bahria University |
2025-01-01 | PHASE4 |
| NCT06068686 | COMPLETED | Type 2 Diabetes |
Damanhour University |
2022-10-01 | |
| NCT04841096 | COMPLETED | Type 2 Diabetes |
Laboratorios Silanes S.A. de C.V. |
2023-03-21 | PHASE3 |
| NCT05386186 | UNKNOWN | Diabetes Mellitus, Type 2; Severe Insulin Deficient Diabetes |
Peking University People's Hospital |
2022-01-01 | PHASE4 |
| NCT05663736 | UNKNOWN | Ejection Fraction |
Seoul National University Bundang Hospital |
2020-01-01 | PHASE4 |
| NCT04528212 | COMPLETED | Diabetes Mellitus, Type 2 |
Rehab Werida |
2020-11-01 | PHASE4 |
| NCT02338921 | COMPLETED | Type 2 Diabetes |
Seoul National University Bundang Hospital |
2015-01 | PHASE4 |
| NCT04183868 | COMPLETED | Type 2 Diabetes; Cardiovascular Risk Factor |
University of Catanzaro |
2016-04 | PHASE4 |
| NCT01794143 | COMPLETED | Type 2 Diabetes; Comparative Effectiveness of Glycemia-lowering Medications |
GRADE Study Group |
2013-05 | PHASE3 |
| NCT02609815 | COMPLETED | Diabetes |
Seoul National University Bundang Hospital |
2015-11-01 | |
| NCT04287387 | UNKNOWN | Type2 Diabetes Mellitus |
Peking Union Medical College Hospital |
2020-03-02 | PHASE4 |
| NCT03907423 | COMPLETED | Diabetes Mellitus, Type 2 |
Rehab Werida |
2019-04-01 | |
| NCT02649465 | COMPLETED | Non-alcoholic Fatty Liver Disease |
Kanazawa University |
2015-11-11 | PHASE4 |
| NCT05468879 | COMPLETED | Drug Use |
PT Harsen Laboratories |
2020-09-21 | |
| NCT03917940 | COMPLETED | Diabetic Patients |
Damanhour University |
2019-01-31 | |
| NCT00679237 | COMPLETED | Coronary Heart Disease |
Sorlandet Hospital HF |
2007-09 | |
| NCT03693560 | COMPLETED | Coronary Artery Disease; Diabetes Mellitus, Type 2 |
Damanhour University |
2018-10-08 | PHASE4 |
| NCT02973477 | COMPLETED | Type2 Diabetes; Cardiovascular Diseases |
University of Michigan |
2017-01-12 | PHASE4 |
| NCT03332771 | COMPLETED | Type 2 Diabetes Mellitus |
Lexicon Pharmaceuticals |
2017-12-01 | PHASE3 |
| NCT02769481 | COMPLETED | Type 2 Diabetes Mellitus |
Theracos |
2016-08-15 | PHASE3 |
| NCT04470310 | UNKNOWN | Type 2 Diabetes Mellitus |
Seoul National University Hospital |
2015-12-31 | PHASE4 |
| NCT03791580 | Unknown status | Fall|Congestive Heart Failure|Chronic Kidney Failure|Adverse Drug Event |
RAND|Northwestern University|University of California Los Angeles|University of Southern California|University of Pittsburgh|National Institute on Aging (NIA) |
2019-02-11 | Not Applicable |
| NCT03118713 | TERMINATED | Type 2 Diabetes Mellitus |
Astellas Pharma Korea, Inc. |
2017-04-25 | PHASE4 |
| NCT02919059 | UNKNOWN | Diabetes Mellitus, Type 2 |
IInstituto Gallego de Medicina Vascular |
2016-12-13 | PHASE4 |
| NCT02694263 | COMPLETED | Diabetes Mellitus, Type 2 |
University of Leicester |
2016-07 | PHASE4 |
| NCT01243424 | COMPLETED | Diabetes Mellitus, Type 2 |
Boehringer Ingelheim |
2010-11-11 | PHASE3 |
| NCT02985242 | TERMINATED | Diabetes Mellitus, Type II |
Hannover Medical School |
2017-06-12 | PHASE4 |
| NCT03081676 | COMPLETED | Maturity-Onset Diabetes of the Young, Type 3 |
University Hospital, Gentofte, Copenhagen |
2017-03-08 | |
| NCT01951339 | COMPLETED | Type 2 Diabetes; Cardiovascular Disease |
University of Colorado, Denver |
2013-10 | |
| NCT03060980 | TERMINATED | Diabetes Mellitus, Type 2 |
Intarcia Therapeutics |
2017-03-03 | PHASE3 |
| NCT02564926 | COMPLETED | Diabetes Mellitus, Type 2 |
AstraZeneca |
2016-01-05 | PHASE4 |
| NCT02630706 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2015-12-16 | PHASE3 |
| NCT02567994 | COMPLETED | Type 2 Diabetes Mellitus |
Handok Inc. |
2015-04 | PHASE3 |
| NCT02728453 | TERMINATED | Diabetes Mellitus Type 2 |
Hannover Medical School |
2016-04-27 | PHASE4 |
| NCT02419612 | COMPLETED | Diabetes |
AstraZeneca |
2015-08-14 | PHASE3 |
| NCT02033889 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-12-13 | PHASE3 |
| NCT02528019 | UNKNOWN | Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications |
Kurume University |
2015-08 | PHASE4 |
| NCT04237493 | COMPLETED | Diabetes Mellitus, Type 2 |
University of Jordan |
2017-02-14 | PHASE4 |
| NCT02964572 | COMPLETED | Type2 Diabetes Mellitus |
Yonsei University |
2016-11 | |
| NCT02301806 | UNKNOWN | Type 2 Diabetes |
Dokkyo Medical University |
2015-01 | PHASE4 |
| NCT03009513 | COMPLETED | Diabetes Mellitus |
Handok Inc. |
2017-01 | PHASE1 |
| NCT01999218 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-12-16 | PHASE3 |
| NCT02462369 | UNKNOWN | Microalbuminuria; Microalbuminuria /Creatinine Ratios ACR |
The Second Hospital of Nanjing Medical University |
2015-06 | PHASE4 |
| NCT02471404 | COMPLETED | Type 2 Diabetes Mellitus; Inadequate Glycaemic Control |
AstraZeneca |
2015-09-21 | PHASE4 |
| NCT02956044 | COMPLETED | Type2 Diabetes Mellitus |
Theracos |
2016-11 | PHASE1 |
| NCT02954822 | COMPLETED | Type2 Diabetes |
Dong-A ST Co., Ltd. |
2016-11-14 | PHASE1 |
| NCT02973477 | Completed | Type2 Diabetes|Cardiovascular Diseases |
University of Michigan|AstraZeneca |
2017-01-12 | Phase 4 |
| NCT02373865 | TERMINATED | Diabetes Mellitus Type 2 |
GWT-TUD GmbH |
2015-09 | PHASE4 |
| NCT02919059 | Unknown status | Diabetes Mellitus Type 2 |
IInstituto Gallego de Medicina Vascular |
2016-12-13 | Phase 4 |
| NCT02964572 | Completed | Type2 Diabetes Mellitus |
Yonsei University |
2016-11 | Not Applicable |
| NCT02484209 | WITHDRAWN | Diabetes Mellitus |
Diabetes Frail Ltd |
2016-02 | PHASE3 |
| NCT02280486 | COMPLETED | Type 2 Diabetes |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
2015-01 | PHASE4 |
| NCT02089126 | UNKNOWN | Type 2 Diabetes Mellitus |
LG Life Sciences |
2014-06 | PHASE3 |
| NCT01425580 | COMPLETED | Congestive Heart Failure; Type 2 Diabetes Mellitus |
Thomas Nystrom |
2012-01 | PHASE2 |
| NCT01958671 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-10-09 | PHASE3 |
| NCT02036515 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2014-03-12 | PHASE3 |
| NCT02099110 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2014-04-22 | PHASE3 |
| NCT02312063 | COMPLETED | Diabetes Mellitus, Type 2 |
Kansai Electric Power Hospital |
2015-02 | PHASE4 |
| NCT02106104 | COMPLETED | Type 2 Diabetes |
Amsterdam UMC, location VUmc |
2014-03 | PHASE4 |
| NCT01755156 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-01-11 | PHASE3 |
| NCT02226003 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2014-09-23 | PHASE3 |
| NCT02007278 | COMPLETED | Type 2 Diabetes; Hypoglycemia |
Novartis Pharmaceuticals |
2014-01-03 | PHASE4 |
| NCT02443922 | UNKNOWN | Type 2 Diabetes |
Foundation for the National Institutes of Health |
2015-06 | |
| NCT02426294 | UNKNOWN | Type 2 Diabetes Mellitus |
Pusan National University Hospital |
2015-02 | PHASE4 |
| NCT02026310 | COMPLETED | Diabetes Mellitus, Type 2 |
Qifu Li |
2014-01 | |
| NCT02072096 | TERMINATED | Diabetes Mellitus, Type 2 |
Eli Lilly and Company |
2014-02 | PHASE4 |
| NCT02142309 | UNKNOWN | Type 2 Diabetes |
University of Campania Luigi Vanvitelli |
2005-10 | PHASE4 |
| NCT01812122 | COMPLETED | Diabetes Mellitus, Non-Insulin-Dependent |
Seoul National University Hospital |
2013-03 | PHASE4 |
| NCT01717313 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-12-05 | PHASE3 |
| NCT02395237 | WITHDRAWN | Healthy |
Pharmaceutical Research Unit, Jordan |
2015-05 | PHASE1 |
| NCT01709305 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-11-08 | PHASE4 |
| NCT01990469 | COMPLETED | T2DM |
LG Life Sciences |
2014-01 | PHASE3 |
| NCT01682759 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-09-10 | PHASE3 |
| NCT01183104 | COMPLETED | Type 2 Diabetes |
Japan Association for Diabetes Education and Care |
2010-08 | |
| NCT01704261 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-10-18 | PHASE3 |
| NCT01769378 | COMPLETED | Type 2 Diabetes Mellitus |
Eli Lilly and Company |
2013-01 | PHASE3 |
| NCT01841697 | COMPLETED | Type 2 Diabetes |
Merck Sharp & Dohme LLC |
2013-06-13 | PHASE3 |
| NCT01910441 | TERMINATED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2013-07 | PHASE4 |
| NCT01644500 | COMPLETED | Type 2 Diabetes Mellitus |
Eli Lilly and Company |
2012-07 | PHASE3 |
| NCT01890629 | COMPLETED | Type 2 Diabetes Mellitus |
LG Life Sciences |
2013-05 | PHASE4 |
| NCT01455883 | WITHDRAWN | Type 2 Diabetes |
Intarcia Therapeutics |
2013-02 | PHASE3 |
| NCT01455922 | WITHDRAWN | Type 2 Diabetes |
Intarcia Therapeutics |
2013-02 | PHASE3 |
| NCT00858013 | COMPLETED | Type 2 Diabetes Mellitus |
Ajou University School of Medicine |
2009-04-24 | PHASE4 |
| NCT01590771 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-07-09 | PHASE3 |
| NCT01341717 | COMPLETED | Diabetes Mellitus, Type 2 |
Jothydev's Diabetes and Research Centre |
2012-02 | PHASE4 |
| NCT01863667 | TERMINATED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2013-07-08 | PHASE3 |
| NCT01699932 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2012-09 | PHASE3 |
| NCT01481116 | TERMINATED | Diabetes Mellitus, Type 2 |
Takeda |
2012-01 | PHASE3 |
| NCT01829477 | TERMINATED | Diabetes Mellitus, Type 2 |
Takeda |
2013-04 | PHASE3 |
| NCT01703286 | COMPLETED | Diabetes Mellitus, Type 2 |
Boehringer Ingelheim |
2012-10 | PHASE1 |
| NCT01459809 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2012-02 | PHASE3 |
| NCT01593137 | WITHDRAWN | Type 2 Diabetes |
Fundación Fernández-Cruz |
2012-05 | PHASE4 |
| NCT01678820 | TERMINATED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-10-10 | PHASE3 |
| NCT00993187 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2010-05-04 | PHASE4 |
| NCT01649466 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2012-08 | PHASE4 |
| NCT01725672 | TERMINATED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2012-09-27 | PHASE1 |
| NCT01610934 | COMPLETED | Maturity-onset Diabetes of the Young |
University Hospital, Gentofte, Copenhagen |
2012-08 | PHASE2; PHASE3 |
| NCT01167881 | COMPLETED | Diabetes Mellitus, Type 2 |
Boehringer Ingelheim |
2010-08 | PHASE3 |
| NCT01494987 | COMPLETED | Type 2 Diabetes Mellitus |
Gilead Sciences |
2012-01 | PHASE3 |
| NCT01699737 | COMPLETED | Type 2 Diabetes Mellitus |
Akros Pharma Inc. |
2012-09 | PHASE2 |
| NCT01768455 | COMPLETED | Healthy |
LG Life Sciences |
2013-02 | PHASE1 |
| NCT01819402 | UNKNOWN | To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging |
Kurume University |
2012-03 | |
| NCT01495013 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2011-12 | PHASE3 |
| NCT01177384 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2011-01-25 | PHASE3 |
| NCT01457911 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2011-10 | PHASE3 |
| NCT01614769 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-07-18 | PHASE1 |
| NCT01357252 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2011-04 | PHASE3 |
| NCT01517373 | COMPLETED | Diabetes Mellitus, Type 2 |
Pfizer |
2012-02 | PHASE2 |
| NCT01477853 | TERMINATED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2011-10-24 | PHASE3 |
| NCT01660386 | UNKNOWN | Type 2 Diabetes |
Shanghai Jiao Tong University School of Medicine |
2012-07 | PHASE4 |
| NCT01585792 | COMPLETED | Diabetic Patients |
Takeda |
2012-05 | PHASE3 |
| NCT01565096 | UNKNOWN | Diabetes Mellitus Type II |
ikfe-CRO GmbH |
2011-11 | PHASE4 |
| NCT00775684 | COMPLETED | Pre-diabetes; Type 2 Diabetes |
University of Pennsylvania |
2008-10 | |
| NCT01189890 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2010-08-16 | PHASE3 |
| NCT01547104 | UNKNOWN | Diabetes Mellitus Type 2 |
Marcus Borchert |
2012-04 | PHASE4 |
| NCT01408095 | WITHDRAWN | Diabetes Mellitus, Type 2 |
Eli Lilly and Company |
2011-09 | PHASE2 |
| NCT00474838 | COMPLETED | Type 2 Diabetes Mellitus; Pancreatic Beta Cell Function; Glucotoxicity |
Kyunghee University Medical Center |
2007-04 | PHASE4 |
| NCT00949442 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2009-07 | PHASE4 |
| NCT01006603 | COMPLETED | Type 2 Diabetes Mellitus |
AstraZeneca |
2009-10 | PHASE4 |
| NCT01496443 | COMPLETED | Pharmacokinetics |
Takeda |
2012-01 | PHASE1 |
| NCT01075282 | COMPLETED | Diabetes Mellitus, Type 2 |
Eli Lilly and Company |
2010-02 | PHASE3 |
| NCT01087502 | COMPLETED | Diabetes Mellitus, Type 2 |
Boehringer Ingelheim |
2010-03 | PHASE3 |
| NCT01404676 | COMPLETED | Type 2 Diabetes Mellitus |
Samsung Medical Center |
2010-06 | PHASE4 |
| NCT01570660 | COMPLETED | Type 2 Diabetes Mellitus |
German Diabetes Center |
2002-02 | |
| NCT01204580 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2010-12 | PHASE4 |
| NCT01296412 | COMPLETED | Diabetes Mellitus, Type 2 |
Merck Sharp & Dohme LLC |
2011-03-11 | PHASE3 |
| NCT01561976 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2012-01-30 | |
| NCT01509001 | COMPLETED | Type 2 Diabetes |
University of Sao Paulo |
2011-01 | PHASE4 |
| NCT00838903 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2009-02 | PHASE3 |
| NCT00839527 | COMPLETED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2009-02 | PHASE3 |
| NCT01444248 | COMPLETED | Type 2 Diabetes Mellitus |
Handok Inc. |
2010-08 | PHASE4 |
| NCT00968812 | COMPLETED | Diabetes Mellitus, Type 2 |
Janssen Research & Development, LLC |
2009-09 | PHASE3 |
| NCT01472497 | COMPLETED | Hypertension; Insulin Resistance |
Tottori University Hospital |
2007-04 | PHASE4 |
| NCT01233622 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis |
2010-10 | PHASE3 |
| NCT01076075 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2010-06-03 | PHASE3 |
| NCT01123980 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2010-05 | PHASE4 |
| NCT00939939 | TERMINATED | Diabetes Mellitus Type 2 |
Ludwig-Maximilians - University of Munich |
2010-03 | PHASE4 |
| NCT00359762 | COMPLETED | Type 2 Diabetes Mellitus |
AstraZeneca |
2006-09 | PHASE3 |
| NCT01262586 | COMPLETED | Type II Diabetes Mellitus |
Novartis Pharmaceuticals |
2010-11 | PHASE3 |
| NCT01677247 | COMPLETED | Glimepiride BE Study in Healthy Volunteers Under Fasting Condition |
Dexa Medica Group |
2011-02 | |
| NCT01437800 | COMPLETED | Healthy |
Laboratorios Silanes S.A. de C.V. |
2011-01 | PHASE1 |
| NCT01437813 | COMPLETED | Healthy |
Laboratorios Silanes S.A. de C.V. |
2011-01 | PHASE1 |
| NCT00622284 | COMPLETED | Diabetes Mellitus, Type 2 |
Boehringer Ingelheim |
2008-02 | PHASE3 |
| NCT01144728 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2010-05 | PHASE4 |
| NCT00913367 | COMPLETED | Type 2 Diabetes Mellitus |
Handok Inc. |
2009-05 | PHASE4 |
| NCT00957060 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2009-07 | PHASE4 |
| NCT00562172 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2007-09 | PHASE4 |
| NCT01453049 | TERMINATED | Diabetes Mellitus, Type 2 |
GlaxoSmithKline |
2010-04 | PHASE3 |
| NCT01007097 | COMPLETED | Diabetes Mellitus, Type 2 |
Takeda |
2009-12 | PHASE2 |
| NCT00908921 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2009-04 | PHASE4 |
| NCT00747383 | COMPLETED | Type 2 Diabetes Mellitus |
The Royal Bournemouth Hospital |
2008-09 | |
| NCT00740051 | COMPLETED | Diabetes Mellitus, Type 2 |
Boehringer Ingelheim |
2008-08 | PHASE3 |
| NCT01089790 | TERMINATED | Diabetes Mellitus, Type 2 |
Forest Laboratories |
2010-03 | PHASE3 |
| NCT00947557 | TERMINATED | Diabetes Mellitus, Type II |
Forest Laboratories |
2009-07 | PHASE3 |
| NCT00699322 | UNKNOWN | Type 2 Diabetes |
The Catholic University of Korea |
2008-06 | PHASE4 |
| NCT01133431 | COMPLETED | Healthy Male Volunteer |
Chong Kun Dang Pharmaceutical |
2010-05 | PHASE1 |
| NCT00620282 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2008-02 | PHASE3 |
| NCT00941161 | COMPLETED | Type 2 Diabetes Mellitus |
Laboratorios Silanes S.A. de C.V. |
2009-02 | PHASE4 |
| NCT01302158 | COMPLETED | Healthy Subjects |
Astellas Pharma Inc |
2009-12 | PHASE1 |
| NCT00924573 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2009-05 | PHASE3 |
| NCT00792935 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2009-01 | PHASE2 |
| NCT01318135 | COMPLETED | Type 2 Diabetes Mellitus |
Takeda |
2009-01 | PHASE2; PHASE3 |
| NCT00708578 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2008-05 | PHASE4 |
| NCT00680745 | COMPLETED | Type 2 Diabetes |
AstraZeneca |
2008-04 | PHASE3 |
| NCT00701090 | COMPLETED | Type 2 Diabetes Mellitus, Non Insulin Dependent; Diabetes Mellitus, Non-Insulin-Dependent |
Merck Sharp & Dohme LLC |
2008-05 | PHASE3 |
| NCT02172261 | COMPLETED | Healthy |
Boehringer Ingelheim |
2009-04 | PHASE1 |
| NCT00842556 | COMPLETED | Type 2 Diabetes Mellitus |
AstraZeneca |
2009-03 | PHASE1 |
| NCT00770653 | COMPLETED | Diabetes Mellitus; Dyslipidemias |
Takeda |
2007-04 | PHASE3 |
| NCT00612144 | COMPLETED | Type 2 Diabetes Mellitus |
Handok Inc. |
2007-12 | PHASE4 |
| NCT01318083 | COMPLETED | Type 2 Diabetes Mellitus |
Takeda |
2008-08 | PHASE2; PHASE3 |
| NCT00722631 | COMPLETED | Impaired Glucose Tolerance; Type 2 Diabetes Mellitus; Atherosclerosis |
Kurume University |
2007-05 | |
| NCT00614120 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2008-01 | PHASE3 |
| NCT00770952 | COMPLETED | Diabetes Mellitus |
Takeda |
2006-12 | PHASE3 |
| NCT00449605 | TERMINATED | Diabetes Mellitus, Type 2 |
Sanofi |
2007-03 | PHASE3 |
| NCT00934323 | COMPLETED | Healthy |
Handok Inc. |
2008-10 | PHASE1 |
| NCT00294723 | TERMINATED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-02 | PHASE3 |
| NCT00360698 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2006-07 | PHASE4 |
| NCT00562250 | COMPLETED | Diabetes Mellitus, Type 2 |
AstraZeneca |
2008-05 | PHASE1 |
| NCT00032487 | COMPLETED | Type 2 Diabetes Mellitus |
VA Office of Research and Development |
2000-12-01 | PHASE3 |
| NCT00106340 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-03 | PHASE3 |
| NCT00469586 | TERMINATED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2007-04-26 | PHASE3 |
| NCT00469092 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2007-05 | PHASE4 |
| 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 |
| NCT00363519 | COMPLETED | Type 2 Diabetes Mellitus |
Ono Pharmaceutical Co., Ltd. |
2006-08 | PHASE3 |
| NCT01429818 | COMPLETED | Endothelial Dysfunction; Diabetes Mellitus |
Laboratorios Silanes S.A. de C.V. |
2007-07 | PHASE4 |
| NCT00318656 | COMPLETED | Non-Insulin-Dependent Diabetes Mellitus |
GlaxoSmithKline |
2005-11 | PHASE4 |
| NCT00225277 | COMPLETED | Diabetes Mellitus |
Takeda |
2003-07 | PHASE3 |
| NCT01511692 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2005-11 | PHASE1 |
| NCT00309608 | COMPLETED | Diabetes Mellitus, Type 2 |
Boehringer Ingelheim |
2006-04 | PHASE2 |
| NCT00318461 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-05 | PHASE3 |
| NCT00318422 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-05 | PHASE3 |
| NCT00934817 | COMPLETED | Healthy |
Handok Inc. |
2007-03 | PHASE1 |
| NCT00331851 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2006-05 | PHASE3 |
| NCT00106704 | COMPLETED | Diabetes Mellitus, Type 2 |
Merck Sharp & Dohme LLC |
2005-03 | PHASE3 |
| NCT00225264 | COMPLETED | Diabetes Mellitus |
Takeda |
2003-10 | PHASE3 |
| NCT00138580 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-11 | PHASE3 |
| NCT00095030 | COMPLETED | Diabetes Mellitus, Type 2 |
Bristol-Myers Squibb |
2004-02 | PHASE3 |
| NCT00258804 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2005-05 | PHASE4 |
| NCT00099944 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-05 | PHASE3 |
| NCT00619697 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2003-12 | PHASE4 |
| NCT00650533 | COMPLETED | Healthy |
Mylan Pharmaceuticals Inc |
2004-11 | PHASE1 |
| NCT00648362 | COMPLETED | Healthy |
Mylan Pharmaceuticals Inc |
2004-11 | PHASE1 |
| NCT00608179 | COMPLETED | Type 2 Diabetes |
Vanderbilt University |
2002-08 | |
| NCT01053689 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2003-12 | PHASE1 |
| NCT01052909 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2003-12 | PHASE1 |
| NCT00776490 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2003-07 | |
| NCT00783744 | COMPLETED | Diabetes Mellitus, Type 2 |
Sanofi |
2001-12 | PHASE3 |
| NCT00776620 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2003-07 | |
| NCT00835172 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2003-03 | PHASE1 |
| NCT00834340 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2003-02 | PHASE1 |
| NCT01511172 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2002-08 | PHASE2 |
| NCT01509755 | COMPLETED | Diabetes; Diabetes Mellitus, Type 2 |
Novo Nordisk A/S |
2000-10 | PHASE2 |
| NCT00576784 | COMPLETED | Type 2 Diabetes Mellitus; Insulin Resistance |
IKFE Institute for Clinical Research and Development |
2005-04 | PHASE4 |
| NCT00549263 | WITHDRAWN | Healthy Subjects |
GlaxoSmithKline |
2008-02 | PHASE1 |
| NCT00437554 | COMPLETED | Diabetes Mellitus, Type 2 |
Handok Inc. |
2006-08 | PHASE3 |
| NCT00633425 | COMPLETED | Diabetes Mellitus |
Sanofi |
2002-10 | PHASE4 |
| NCT00353691 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2002-10 | PHASE3 |
| NCT00044447 | COMPLETED | Diabetes Mellitus, Non-Insulin-Dependent |
Sanofi |
2001-05 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2025-12-17)
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>).