Drugs / Glimepiride
last change May 2026 re-read 2 minutes ago

Glimepiride

Small molecule

Developed for
type 2 diabetes mellitus · diabetes mellitus · congestive heart failure · coronary artery disorder · heart failure · maturity-onset diabetes of the young type 1 · maturity-onset diabetes of the young type 3 · type 1 diabetes mellitus
+7 more · atherosclerosis · glucose intolerance · hyperlipidemia · maturity-onset diabetes of the young · NAFLD1 · prediabetes syndrome · proteinuria
Investigated by
Sanofi · Merck Sharp & Dohme LLC · Handok Inc. · Laboratorios Silanes S.A. de C.V. · Takeda · AstraZeneca
+75 more · Boehringer Ingelheim · Eli Lilly and Company · GlaxoSmithKline · LG Life Sciences · Mexican Social Security Institute · Mylan Pharmaceuticals Inc · Novo Nordisk A/S · University of Campania Luigi Vanvitelli · Amylin Pharmaceuticals, LLC. · Anhui Provincial Hospital · Asker & Baerum Hospital · Associazione Medici Diabetologi (AMD) · Associazione Nazionale Medici Cardiologi Ospedalieri · Astellas Pharma Inc · Astellas Pharma Inc · Beijing Anzhen Hospital · Chinese Academy of Medical Sciences, Fuwai Hospital · Chinese Academy of Sciences · Chong Kun Dang Pharmaceutical · Chongqing Medical University · Daewoong Pharmaceutical Co. LTD. · Damanhour University · Diabetes Frail Ltd · Dong-A ST Co., Ltd. · Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · First Affiliated Hospital of Xinjiang Medical University · First Hospital of China Medical University · Foundation for the National Institutes of Health · GWT-TUD GmbH · Haukeland University Hospital · Huaxi Hospital · Intarcia Therapeutics · Italian Society of Diabetology · Jiangsu Province Geriatric Institute · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Jothydev's Diabetes and Research Centre · Juvenile Diabetes Research Foundation · Nanjing Medical University · National Eye Institute (NEI) · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Novartis · Peking Union Medical College Hospital · Peking University First Hospital · Peking University People's Hospital · Pfizer · Pharmaceutical Research Unit, Jordan · Qifu Li · Rijnstate Hospital · Rikshospitalet University Hospital · Sahlgrenska University Hospital · Second Xiangya Hospital of Central South University · Seoul National University Hospital · Shanghai Jiao Tong University School of Medicine · Shanghai Zhongshan Hospital · SmithKline Beecham · Southwest Medical University · Tanta University · Teva Pharmaceuticals USA · The First Affiliated Hospital of Air Force Medicial University · The First Affiliated Hospital of Zhengzhou University · Thomas Nystrom · Tianjin Medical University · Tongji Hospital · University Hospital, Aker · University of Abuja Teaching Hospital · University of Jordan · University of Michigan · VA Office of Research and Development · Vanderbilt University · Washington University School of Medicine · Wuhan Central Hospital · Xiangya Hospital · Zhongnan Hospital · all 81 on the full record

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Avaglim 2006-06-27 europa.eu
Label expansions (3) US (FDA) AMARYL 1999-02-24 – 2005-11-28 fda.gov
Approved US (FDA) AMARYL 1995-11-30 fda.gov

Trials 71 · started per year

today
US approved 1995
EU approved 2006
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1995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 117 trials
Phase 1 NCT06644404 Oct → Dec 2024 overdue Daewoong Pharmaceutical Co. LTD. Not yet recruiting No outcome recorded
Phase 1 NCT03009513 Jan → May 2017 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 1 NCT02954822 Nov 2016 → Jan 2017 type 2 diabetes mellitus Dong-A ST Co., Ltd. Completed No outcome recorded
Phase 1 NCT02395237 May 2015 Pharmaceutical Research Unit, Jordan Withdrawn No outcome recorded
Phase 1 NCT01768455 Feb → Apr 2013 LG Life Sciences Completed No outcome recorded
Phase 1 NCT01614769 Jul 2012 → Jan 2013 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT01496443 Jan → May 2012 Takeda Completed No outcome recorded
Phase 1 NCT01437813 Jan 2011 Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 1 NCT01437800 Jan 2011 Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 1 NCT01133431 May → Jun 2010 Chong Kun Dang Pharmaceutical Completed No outcome recorded
Phase 21 trial
Phase 2 NCT01425580 Jan 2012 → Aug 2016 congestive heart failure, type 2 diabetes mellitus Thomas Nystrom Completed No outcome recorded
Phase 320 trials
Phase 3 NCT07288749 Jan 2026 → Dec 2030 expected heart failure, type 2 diabetes mellitus Tongji Hospital Not yet recruiting No outcome recorded
Phase 3 NCT04841096 Mar 2023 → Mar 2024 type 2 diabetes mellitus Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 3 NCT03060980 Mar 2017 → Jan 2018 type 2 diabetes mellitus Intarcia Therapeutics Terminated No outcome recorded
Phase 3 NCT02484209 Feb → Oct 2016 diabetes mellitus Diabetes Frail Ltd Withdrawn No outcome recorded
Phase 3 NCT02419612 Aug 2015 → Aug 2017 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 3 NCT01863667 Jul 2013 → Apr 2014 type 2 diabetes mellitus Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT01699932 Sep 2012 → Apr 2014 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT01459809 Feb 2012 → Jan 2014 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT01477853 Oct 2011 → Dec 2012 type 2 diabetes mellitus Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT01296412 Mar 2011 → Feb 2012 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 428 trials
Phase 4 NCT05386186 Jan 2022 → Oct 2023 type 2 diabetes mellitus Peking University People's Hospital Unknown No outcome recorded
Phase 4 NCT04287387 Mar 2020 → Mar 2021 type 2 diabetes mellitus Peking Union Medical College Hospital Unknown No outcome recorded
Phase 4 NCT03693560 Oct 2018 → Sep 2019 coronary artery disorder, type 2 diabetes mellitus Damanhour University Completed No outcome recorded
Phase 4 NCT03804411 Aug 2017 → Mar 2020 type 2 diabetes mellitus Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Unknown No outcome recorded
Phase 4 NCT03118713 Apr 2017 → Dec 2018 type 2 diabetes mellitus Astellas Pharma Inc Terminated No outcome recorded
Phase 4 NCT04239586 Apr 2017 → Apr 2022 maturity-onset diabetes of the young type 1, maturity-onset diabetes of the young type 3, type 1 diabetes mellitus Haukeland University Hospital Unknown No outcome recorded
Phase 4 NCT04237493 Feb → Jul 2017 type 2 diabetes mellitus University of Jordan Completed No outcome recorded
Phase 4 NCT02973477 Jan 2017 → Aug 2019 cardiovascular disorder, type 2 diabetes mellitus University of Michigan Completed No outcome recorded
Phase 4 NCT02373865 Sep 2015 → Jan 2017 type 2 diabetes mellitus GWT-TUD GmbH Terminated No outcome recorded
Phase 4 NCT01890629 May 2013 → Aug 2014 type 2 diabetes mellitus LG Life Sciences Completed No outcome recorded
Phase not applicable5 trials
NCT07589387 May 2026 → Apr 2029 expected diabetes mellitus Washington University School of Medicine Not yet recruiting No outcome recorded
NCT02443922 Jun → Dec 2015 type 2 diabetes mellitus Foundation for the National Institutes of Health Unknown No outcome recorded
NCT02026310 Jan 2014 → Nov 2015 type 2 diabetes mellitus Qifu Li Completed No outcome recorded
NCT00978263 Feb 2009 → Dec 2011 diabetes mellitus Chongqing Medical University Completed No outcome recorded
NCT00608179 Aug 2002 → Sep 2004 type 2 diabetes mellitus Vanderbilt University Completed No outcome recorded
Also used as a comparator or background therapy in 153 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT02956044 Comparator Nov 2016 → Mar 2017 type 2 diabetes mellitus Theracos Completed No outcome recorded
Phase 1 NCT01703286 Comparator Oct 2012 → Jan 2014 type 2 diabetes mellitus Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT01725672 Comparator Sep 2012 → Aug 2013 type 2 diabetes mellitus GlaxoSmithKline Terminated No outcome recorded
Phase 1 NCT00842556 Comparator Mar → May 2009 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 1 NCT00562250 Comparator May → Aug 2008 type 2 diabetes mellitus AstraZeneca Completed No outcome recorded
Phase 29 trials
Phase 2 NCT02111096 Background Apr 2014 → Sep 2015 type 2 diabetes mellitus Eli Lilly and Company Terminated No outcome recorded
Phase 2 NCT01699737 Comparator Sep 2012 → May 2013 type 2 diabetes mellitus Akros Pharma Inc. Completed No outcome recorded
Phase 2 NCT01517373 Comparator Feb 2012 → Jan 2013 type 2 diabetes mellitus Pfizer Completed No outcome recorded
Phase 2 NCT01408095 Comparator Sep 2011 → Sep 2012 type 2 diabetes mellitus Eli Lilly and Company Withdrawn No outcome recorded
Phase 2 NCT01007097 Comparator Dec 2009 → Sep 2010 type 2 diabetes mellitus Takeda Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT01610934 Comparator Aug 2012 → Aug 2013 maturity-onset diabetes of the young University Hospital, Gentofte, Copenhagen Completed No outcome recorded
Phase 2/3 NCT01318135 Comparator Jan 2009 → Jan 2010 type 2 diabetes mellitus Takeda Completed No outcome recorded
Phase 2/3 NCT01318083 Comparator Aug 2008 → Apr 2009 type 2 diabetes mellitus Takeda Completed No outcome recorded
Phase 367 trials
Phase 3 NCT03332771 Comparator Dec 2017 → Aug 2019 type 2 diabetes mellitus Lexicon Pharmaceuticals Completed No outcome recorded
Phase 3 NCT03066830 Comparator Feb 2017 → Apr 2019 type 2 diabetes mellitus Lexicon Pharmaceuticals Completed No outcome recorded
Phase 3 NCT02946632 Comparator Dec 2016 → Dec 2019 type 2 diabetes mellitus Korea University Anam Hospital Unknown No outcome recorded
Phase 3 NCT02769481 Comparator Aug 2016 → Jun 2019 type 2 diabetes mellitus Theracos Completed No outcome recorded
Phase 3 NCT02630706 Background Dec 2015 → Dec 2017 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 451 trials
Phase 4 NCT07365358 Comparator Mar 2026 → Aug 2027 expected type 2 diabetes mellitus Chong Kun Dang Pharmaceutical Not yet recruiting No outcome recorded
Phase 4 NCT06759922 Comparator Jan → Mar 2025 type 2 diabetes mellitus Bahria University Completed No outcome recorded
Phase 4 NCT06449235 Comparator Sep 2024 → Apr 2025 overdue type 2 diabetes mellitus Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders Not yet recruiting No outcome recorded
Phase 4 NCT05975528 Comparator Jun 2023 → Dec 2025 type 2 diabetes mellitus Yonsei University Unknown No outcome recorded
Phase 4 NCT04528212 Background Nov 2020 → Nov 2021 type 2 diabetes mellitus Rehab Werida Completed No outcome recorded
Phase not applicable16 trials
NCT06068686 Comparator Oct 2022 → Nov 2024 type 2 diabetes mellitus Damanhour University Completed No outcome recorded
NCT03907423 Comparator Apr 2019 → Jan 2021 type 2 diabetes mellitus Rehab Werida Completed No outcome recorded
NCT03917940 Comparator Jan 2019 → May 2020 Damanhour University Completed No outcome recorded
NCT03180281 Comparator Jul 2017 → Jan 2020 type 2 diabetes mellitus First Affiliated Hospital Xi'an Jiaotong University Unknown No outcome recorded
NCT03081676 Comparator Mar 2017 → Jun 2018 maturity-onset diabetes of the young type 3 University Hospital, Gentofte, Copenhagen Completed No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2005-10-06 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Approval of Glimepiride Tablets tevapharm.com
2005-06-28 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Tentative Approval Of Glimepiride Tablets tevapharm.com

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 229 sources stand behind the page.

FieldValueCited text
Known as glimepiride “The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients...” NCT02314637
217

“The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4...” NCT00379769

Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose” NCT01999218

“Subsequently, patients are assigned to receive either the DPP-4 inhibitor Vildagliptin 50 mg twice daily or the sulfonylurea Glimepiride 2 mg twice daily.” NCT03983551

“The combination of glimepiride(amaryl) and short-acting insulin (novorapid) is thought to attain glycemic control with a smaller increase in body weight.” NCT00151697

glimepiride (starting dose 1 mg/day and up-titrated, based upon patient's self-monitoring of blood glucose results, to a maximum dose of up to 6 mg/day)” PMID 21199268 Feb 2011

“This Arm will include patients receiving Sulphonylureas (Gliclazide/ Glipizide/ Glimepiride/ Tolbutamide) according to the physician's choice.” NCT06449235

“Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription” NCT01131182

“Routine Care patients receive oral medications based upon the 2009 ADA treatment recommendations: Metformin, Glimepiride, Pioglitazone.” NCT01087567

“If the patients fail to achieve the target, gliclazide-MR (Diamicron, Servier), or glimepiride (Amaryl, Sanofi-Aventis) would be added.” NCT00978263

“OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).” NCT01584232

“a sulfonylurea (5-15 mg glibenclamide, 2-6 mg glimepiride, or 30-120 mg gliclazide, in accordance with local practice)” PMID 28917544 Sep 2017

“Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral” NCT03907423

“The combination of glimepiride and metformin is used for glycemic control in patients with diabetes mellitus.” PMID 22036245 Oct 2011

glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin” NCT01099137

“same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets” NCT02395237

“polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)” NCT00133718

“Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.” NCT01340768

Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy” NCT01841697

“subgroup 7A - addition of glimepiride, subgroup 8A - addition of gliclazide” NCT03804411

“Group who takes Glimepiride 2mg+Metformin 500mg, once daily.” NCT02823808

glimepiride 2 mg & metformin HCl 500 mg” NCT00934817

“Gliclazide-MR, Metformin, GlimepirideNCT00506194

“MP-513","Amaryl","glimepirideNCT00974090

Glimepiride 2mg, once daily” NCT06644404

glimepiride (Amaryl)” NCT00000620

Glimepiride 1-2mg qd” NCT03180281

GlimepirideNCT02919059

GlimepirideNCT02946632

GlimepirideNCT01242215

NCT00562250

NCT01459809

NCT04528212

NCT01755156

NCT00318422

NCT04183868

NCT01958671

NCT02973477

NCT01444248

NCT00318461

NCT01404676

NCT05663736

NCT02373865

NCT01509001

NCT03118713

NCT02769481

NCT02954822

NCT00318656

NCT02609815

NCT00437554

NCT00699322

NCT00633425

NCT01177384

NCT01678820

NCT01076075

NCT01794143

NCT00648362

NCT01087502

NCT01075282

NCT02919059

NCT00343980

NCT00722631

NCT01494987

NCT01863667

NCT02026310

NCT01204580

NCT00835172

NCT00620282

NCT02172261

NCT00708578

NCT02528019

NCT00225264

NCT02301806

NCT01341717

NCT00032487

NCT02985242

NCT00225277

NCT03009513

NCT06759922

NCT00427154

NCT00838903

NCT01644500

NCT02007278

NCT05975528

NCT00957060

NCT03332771

NCT02462369

NCT02089126

NCT06068686

NCT01455883

NCT00775684

NCT01183104

NCT01007097

NCT01167881

NCT00619697

NCT05386186

NCT04237493

NCT00908921

NCT02649465

NCT01699932

NCT02728453

NCT01565096

NCT02630706

NCT00044447

NCT00576784

NCT01709305

NCT01829477

NCT00614120

NCT00949442

NCT00622284

NCT00924573

NCT00834340

NCT00679237

NCT01477853

NCT00294723

NCT02036515

NCT02426294

NCT02312063

NCT01144728

NCT00331851

NCT02956044

NCT00941161

NCT01496443

NCT01682759

NCT02142309

NCT02419612

NCT02226003

NCT01517373

NCT00842556

NCT01455922

NCT01429818

NCT01819402

NCT03060980

NCT01509755

NCT00353691

NCT00740051

NCT04287387

NCT01302158

NCT00359762

NCT04470310

NCT00562172

NCT00106340

NCT02280486

NCT02072096

NCT01296412

NCT03917940

NCT01123980

NCT01910441

NCT00309608

NCT01437813

NCT01660386

NCT01704261

NCT01610934

NCT02964572

NCT02471404

NCT00474838

NCT01437800

NCT00839527

NCT07288749

NCT01547104

NCT04841096

NCT00993187

NCT00608179

NCT01318083

NCT00099944

NCT01812122

NCT01769378

NCT01590771

NCT07589387

NCT01511172

NCT02564926

NCT00650533

NCT00939939

NCT00968812

NCT01585792

NCT01189890

NCT01725672

NCT01481116

NCT02099110

NCT00680745

NCT01425580

NCT01593137

NCT01561976

NCT01717313

NCT00360698

NCT00770952

NCT01133431

NCT02484209

NCT01511692

NCT00792935

NCT00913367

NCT01453049

NCT00747383

NCT02694263

NCT02443922

NCT02106104

NCT00449605

NCT01243424

NCT00770653

NCT01890629

NCT01951339

NCT01408095

NCT01699737

NCT01457911

NCT01006603

NCT00469092

NCT07365358

NCT01262586

NCT01768455

NCT01614769

NCT00783744

NCT01495013

NCT01318135

NCT00469586

NCT00858013

NCT03693560

NCT01703286

NCT03081676

Known as Amaryl “commercially available formulations of metformin extended release (XR) (GLUCOPHAGE ™ Sustained Release \[SR\]) and glimepiride immediate release (IR) (AMARYL ™).” NCT01725672
9

“If the patients fail to achieve the target, gliclazide-MR (Diamicron, Servier), or glimepiride (Amaryl, Sanofi-Aventis) would be added.” NCT00978263

“AvandiaTM and AmarylTM combine two antidiabetic agents, rosiglitazone maleate and glimepiride.” NCT00131664

“Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.” NCT00608179

“Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)” NCT00908921

Amaryl® Tablets 1 mg” NCT00650533

AMARYL (Glimepiride)” NCT01457911

NCT00834340

NCT00642915

NCT00151697

Known as Amaryl - glimepiride Amaryl - glimepirideNCT00576784
1

“Amaryl (glimepiride)” NCT01340768

Known as glim “twice-daily biphasic insulin aspart 30 (30% soluble and 70% protaminated insulin aspart; BIAsp 30) plus metformin (met) was compared with once-daily insulin glargine (glarg)...” PMID 17115351 Oct 2006
1

glimepiride (GLIM)” PMID 32052516 Mar 2020

Known as Glimepirida ChEMBL registry synonym — accepted as the source's own label CHEMBL1481
Known as glimepiride (Amaryl) glimepiride (Amaryl)NCT00000620
1

“glimepiride(amaryl)” NCT00474838

Known as Glimepiride component of avandaryl ChEMBL registry synonym — accepted as the source's own label CHEMBL1481
Known as Glimepiride component of duetact ChEMBL registry synonym — accepted as the source's own label CHEMBL1481
Known as glimepiride/metformin fixed combination ClinicalTrials.gov intervention name — accepted as the source's own label NCT00913367
Known as Glimerepiride GlimerepirideNCT04239586
Known as glimpiride ClinicalTrials.gov intervention name — accepted as the source's own label NCT02372955
Known as HOE 490 “Determination of the absolute bioavailability of glimepiride (HOE 490), a new sulphonylurea.” PMID 1490793 Nov 1992
3

“Drug: Glimepiride (HOE490)” NCT00924573

“GLIMEPIRIDE (HOE490)” NCT00957060

“Glimepiride (HOE490)” NCT01457911

Known as Niddaryl ChEMBL registry synonym — accepted as the source's own label CHEMBL1481
Known as NSC-759809 ChEMBL registry synonym — accepted as the source's own label CHEMBL1481
Known as Sulfonylurea ClinicalTrials.gov intervention name — accepted as the source's own label NCT01972724
2

NCT02111096

NCT03066830

Action Inhibit “The cardiovascular protective effect of glimepiride may be related to the EET level increase through sEH inhibition.” PMID 36573717 Dec 2022
Modality Small molecule “Glimepiride and glyburide are both second-generation sulfonlyurea drugs used commonly for treatment of type 2 diabetes.” NCT00608179
Route Oral “Pioglitazone placebo-matching tablets, orally, once daily and glimepiride 1 mg titrated up to 4 mg, capsules, orally, once daily” NCT00225264