Clinical Trials

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academic centers, pharmaceutical companies, and government institutes, these studies encompass completed, terminated, withdrawn, and unknown recruitment statuses.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)

Check the Glimepiride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glimepiride selectively binds to sulfonylurea receptor subunits SUR1, SUR2A, and SUR2B to inhibit ATP-sensitive potassium channels, inducing pancreatic beta-cell membrane depolarization and a subsequent influx of intracellular calcium. This elevated intracellular calcium stimulates insulin exocytosis while enhancing insulin receptor activity, thereby promoting systemic blood glucose reduction and therapeutic glycemic control in patients evaluated for Type 2 diabetes mellitus.

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>).

Note: Technical data last updated: Sep 1, 2026.