Drugs / Glimepiride
last change May 2026 re-read 8 days ago

Glimepiride

Small molecule

Developed for
type 2 diabetes mellitus · diabetes mellitus · congestive heart failure · coronary artery disorder · heart failure · atherosclerosis · glucose intolerance · hyperlipidemia
+5 more · maturity-onset diabetes of the young · maturity-onset diabetes of the young type 3 · NAFLD1 · prediabetes syndrome · proteinuria
Investigated by
Sanofi · Merck Sharp & Dohme LLC · Handok Inc. · Laboratorios Silanes S.A. de C.V. · Takeda · AstraZeneca
+74 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 · 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 · Örebro University, Sweden

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 70 · started per year

today
US approved 1995
EU approved 2006
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 117 trials · 1 met primary · 1 missed
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 Missed primary
Phase 1 NCT01496443 Jan → May 2012 — Takeda Completed No outcome recorded
Phase 1 NCT01437800 Jan 2011 — Laboratorios Silanes S.A. de C.V. Completed No outcome recorded
Phase 1 NCT01437813 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 · 4 met primary
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 Stop: Enrollment
Phase 3 NCT02419612 Aug 2015 → Aug 2017 type 2 diabetes mellitus AstraZeneca Completed Met primary
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 Stop: Business
Phase 3 NCT01296412 Mar 2011 → Feb 2012 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed Met primary
Phase 427 trials · 1 met primary · 3 missed
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 Stop: Enrollment
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 Missed primary
Phase 4 NCT02373865 Sep 2015 → Jan 2017 type 2 diabetes mellitus GWT-TUD GmbH Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT01890629 May 2013 → Aug 2014 type 2 diabetes mellitus LG Life Sciences Completed No outcome recorded
Phase 4 NCT01812122 Mar 2013 → Aug 2015 type 2 diabetes mellitus Seoul National University Hospital 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
Comparator or background therapy149 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 Missed primary
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
Show all 149 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 22

DateIssuerRelease
2021-03-10 Dong-A ST Co., Ltd. Results 동아ST, ‘슈가논’ 심혈관계 안전성 연구 결과 SCI급 국제학술지 게재 donga-st.com ↗
연구 결과 에보글립틴은 설포닐유레아(Sulfonylurea, SU) 제제인 글리메피리드 대비 심혈관계 사건 누적 발생률이 33%, 뇌혈관계 사건 누적 발생률이 59%로 유의성있게 낮은 결과를 보였으며 협심증, 심부전, 일과성 허혈성 발작의 위험 증가와는 유의한 연관성을 보이지 않았다.
2019-06-10 Eli Lilly and Company Results Detailed findings from CAROLINA® outcome trial support long-term cardiovascular safety profile of Tradjenta® lilly.com ↗
Tradjenta was similar to glimepiride in the secondary endpoint of 3P-MACE plus hospitalization for unstable angina (4P-MACE) (13.2% for Tradjenta versus 13.3% for glimepiride).
2019-02-14 Eli Lilly and Company Results Boehringer Ingelheim and Lilly announce the CAROLINA® cardiovascular outcome trial of Tradjenta® met its primary endpoint of non-inferiority compared with glimepiride lilly.com ↗
2015-12-01 Eli Lilly and Company Results New Data Show Lilly's Once-Weekly Trulicity® (dulaglutide) is Effective as Add-on Treatment to Sulfonylurea lilly.com ↗
New data from a completed Phase 3 trial show Trulicity® (dulaglutide) 1.5 mg plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering hemoglobin A1c (A1C) from baseline after 24 weeks of treatment.
2013-06-24 GlaxoSmithKline Results GSK announces data from five Phase III studies of albiglutide, an investigational once-weekly treatment for type 2 diabetes gsk.com ↗
At Week 104, the reduction in HbA1c was statistically significant in the albiglutide group compared to those treated with placebo (-0.9%; p<0.0001), sitagliptin (-0.4%; p=0.0001), or glimepiride (-0.3%; p=0.003).
2013-06-23 Janssen Research & Development, LLC Results Studies Reinforce INVOKANA™ (canagliflozin) (300mg) Provides Greater Improvements in Blood Glucose than Sitagliptin (100 mg) or Glimepiride (6 or 8 mg) in Adults with Type 2 Diabetes jnj.com ↗
Results of a second Phase 3 study, also in adult patients taking metformin, showed greater improvements in blood glucose control with 300 mg INVOKANA™ and similar improvements with 100 mg INVOKANA™ compared to another commonly prescribed therapy, glimepiride, over a period of 104 weeks.
2013-06-22 Eli Lilly and Company Results Results of new exploratory analyses assessing the incidence of hypoglycemia with linagliptin in adults with type 2 diabetes announced lilly.com ↗
In a separate exploratory analysis of two-year data from a phase III trial comparing linagliptin to glimepiride, fewer people treated with the DPP-4 inhibitor linagliptin versus the sulfonylurea glimepiride experienced hypoglycemia (7.5 percent vs. 36.1 percent; p &#60 0.0001).
2013-06-22 Eli Lilly and Company Results New data about the safety and efficacy of linagliptin in adults with type 2 diabetes who have moderate to severe renal impairment presented at ADA lilly.com ↗
Patients treated with linagliptin had a lower rate of hypoglycemia compared to those treated with glimepiride.
2013-06-11 Eli Lilly and Company Results Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 34 Presentations on Type 1 and Type 2 Diabetes at the 73rd American Diabetes Association Scientific Sessions® lilly.com ↗
Regardless of the degree of glycemic control, linagliptin (LINA) has lower hypoglycemia risk than all doses of glimepiride (GLIM) at all time points over a 2-year trial
2012-06-09 Eli Lilly and Company Results Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company present new linagliptin data at American Diabetes Association's 72nd Scientific Sessions® lilly.com ↗
After 104 weeks of treatment, both linagliptin and glimepiride reduced mean A1C levels by 0.6 percent from baseline (baseline: 7.2 percent linagliptin, 7.3 percent glimepiride) and 76 percent of patients in both groups achieved target A1C &#60 7 percent.
2011-12-08 Bristol-Myers Squibb Results New Data Show Investigational Compound Dapagliflozin When Added to Glimepiride Maintained Reductions in Blood Sugar Levels in Adults with Type 2 Diabetes Over 48 Weeks of Treatment bms.com ↗
In addition to maintaining reductions in blood sugar levels, the 48-week study reported that patients taking dapagliflozin added to glimepiride maintained reductions in fasting plasma glucose levels (FPG), post-prandial glucose (PPG) and total body weight.
2011-06-24 Eli Lilly and Company Results Two-Year Data Comparing Cardiovascular Events with Linagliptin and the Sulfonylurea, Glimepiride, Presented as Late-Breaking Poster at ADA lilly.com ↗
twice as many patients taking glimepiride (26 patients) experienced CV events compared to those taking linagliptin (12 patients), demonstrating a 50 percent reduction in relative risk for the combined CV endpoint

All press releases naming this drug 23 releases

DateIssuerRelease

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 224 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 ↗

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

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

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

Show 207 more sources

Known as Amaryl “commercially available formulations of metformin extended release (XR) (GLUCOPHAGE ™ Sustained Release \[SR\]) and glimepiride immediate release (IR) (AMARYL ™).” NCT01725672 ↗
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“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 (Glimepiride)” NCT01457911 ↗

“Amaryl® Tablets 1 mg” NCT00650533 ↗

NCT00151697 ↗

NCT00642915 ↗

NCT00834340 ↗

Known as Amaryl - glimepiride “Amaryl - glimepiride” NCT00576784 ↗
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 HOE490 “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 ↗
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 ↗