Drugs / Insulin glulisine
last change Dec 2025 re-read 2 minutes ago

Insulin glulisine

Protein / enzyme biologic

Developed for
type 2 diabetes mellitus · type 1 diabetes mellitus · hyperglycemia · diabetes mellitus · Alzheimer disease · chronic obstructive pulmonary disease · cognitive impairment with or without cerebellar ataxia · diabetic ketoacidosis
+5 more · Down syndrome · localized lipodystrophy · myocardial infarction · gestational diabetes · glucose metabolism disease
Investigated by
Sanofi · Emory University · HealthPartners Institute · IKFE Institute for Clinical Research and Development · Medical University of Warsaw · Centre Hospitalier Universitaire Dijon
+26 more · ikfe-CRO GmbH · Ajou University · East West Neo Medical Center · Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Guillermo Umpierrez, MD · Halozyme Therapeutics · Hanyang University · Hospital Universitario Central de Asturias · India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals · Inha University Hospital · Jeju National University Hospital · Kinderkrankenhaus auf der Bult · Korea University Guro Hospital · Kyunghee University Medical Center · Medical University of South Carolina · National Cancer Institute (NCI) · Novo Nordisk A/S · Ohio University · Pontificia Universidad Catolica de Chile · Population Health Research Institute · Texas A&M University · The Catholic University of Korea · The Royal Bournemouth Hospital · Universidad Nacional de Asunción · University of Medicine and Dentistry of New Jersey · Western University of Health Sciences

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) APIDRA SOLOSTAR 2007-04-12 – 2008-10-24 fda.gov
Approved EU (EMA) Apidra 2004-09-27 europa.eu
Approved US (FDA) APIDRA SOLOSTAR 2004-04-16 fda.gov

Trials 67 · started per year

today
US approved 2004
EU approved 2004
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20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT02432716 Apr 2015 → Oct 2018 Down syndrome HealthPartners Institute Completed No outcome recorded
Phase 1 NCT00979875 Sep 2009 → Feb 2010 Halozyme Therapeutics Completed No outcome recorded
Phase 1 NCT01159353 Sep 2007 → Apr 2008 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 1 NCT00824668 Aug → Oct 2007 type 2 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT00310297 Nov → Dec 2004 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 1 NCT00311077 Apr → Oct 2004 diabetes mellitus Sanofi Completed No outcome recorded
Phase 1 NCT00297583 Apr → May 2004 type 1 diabetes mellitus Sanofi Completed No outcome recorded
Phase 1 NCT00368394 Jan 2004 → ? type 1 diabetes mellitus Sanofi Completed No outcome recorded
Phase 1 NCT00290043 Dec 2001 → Mar 2002 type 1 diabetes mellitus Sanofi Completed No outcome recorded
Phase 22 trials
Phase 2 NCT02503501 Sep 2015 → Feb 2019 Alzheimer disease, cognitive impairment with or without cerebellar ataxia HealthPartners Institute Terminated No outcome recorded
Phase 2 NCT01436045 Sep 2011 → Jun 2013 Alzheimer disease HealthPartners Institute Completed No outcome recorded
Phase 319 trials
Phase 3 NCT00943709 May 2009 → Mar 2010 hyperglycemia, leukemia University of Medicine and Dentistry of New Jersey Withdrawn No outcome recorded
Phase 3 NCT00640991 Apr 2008 → Jun 2010 hyperglycemia, myocardial infarction Population Health Research Institute Completed No outcome recorded
Phase 3 NCT00467376 Jan 2007 → Jun 2008 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT00562133 Dec 2006 → Mar 2007 type 2 diabetes mellitus IKFE Institute for Clinical Research and Development Completed No outcome recorded
Phase 3 NCT00272064 Oct 2005 → May 2008 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT00135941 Aug 2005 → Sep 2007 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT00115570 Apr 2005 → Nov 2006 type 1 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT00397553 Jan 2005 → Dec 2007 type 1 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT00174642 Dec 2004 → Dec 2008 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT00290979 Dec 2004 → ? type 1 diabetes mellitus Sanofi Completed No outcome recorded
Phase 435 trials
Phase 4 NCT04019821 Jan 2020 → Jan 2023 type 1 diabetes mellitus Medical University of Warsaw Completed No outcome recorded
Phase 4 NCT04157738 Nov 2019 → Dec 2020 type 1 diabetes mellitus Emory University Completed No outcome recorded
Phase 4 NCT03328845 Jan 2017 → Nov 2020 type 1 diabetes mellitus Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Completed No outcome recorded
Phase 4 NCT02987751 Dec 2016 → Sep 2018 type 2 diabetes mellitus India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals Completed No outcome recorded
Phase 4 NCT02914886 Sep 2016 → Apr 2019 localized lipodystrophy, type 1 diabetes mellitus Kinderkrankenhaus auf der Bult Completed No outcome recorded
Phase 4 NCT02276859 Oct 2014 → Sep 2015 type 1 diabetes mellitus Medical University of Warsaw Completed No outcome recorded
Phase 4 NCT02333851 Jun 2013 → Feb 2014 type 2 diabetes mellitus Hospital Universitario Central de Asturias Terminated No outcome recorded
Phase 4 NCT01234597 Dec 2012 → Apr 2015 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 4 NCT02048189 Mar 2012 → Feb 2015 Centre Hospitalier Universitaire Dijon Terminated No outcome recorded
Phase 4 NCT01889914 Jan 2012 → Mar 2015 type 2 diabetes mellitus Centre Hospitalier Universitaire Dijon Unknown No outcome recorded
Phase not applicable2 trials
NCT01974544 May 2013 → Dec 2015 type 2 diabetes mellitus Pontificia Universidad Catolica de Chile Unknown No outcome recorded
NCT00467636 Jul 2007 → May 2009 chronic obstructive pulmonary disease, hyperglycemia The Royal Bournemouth Hospital Terminated No outcome recorded
Also used as a comparator or background therapy in 41 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00969592 Comparator Nov → Dec 2007 diabetes mellitus Profil Institute for Metabolic Research GmbH Completed No outcome recorded
Phase 29 trials
Phase 2 NCT02846831 Comparator Jan 2019 → Jan 2020 type 1 diabetes mellitus Montreal Clinical Research Institute Completed No outcome recorded
Phase 2 NCT02488616 Comparator Mar → Nov 2018 type 1 diabetes mellitus Montreal Clinical Research Institute Withdrawn No outcome recorded
Phase 2 NCT02490098 Comparator Jan → Jul 2018 type 1 diabetes mellitus Montreal Clinical Research Institute Withdrawn No outcome recorded
Phase 2 NCT02798250 Comparator Jun 2016 → Mar 2017 type 1 diabetes mellitus Montreal Clinical Research Institute Completed No outcome recorded
Phase 2 NCT02626936 Comparator Jan → Jun 2016 type 1 diabetes mellitus Montreal Clinical Research Institute Completed No outcome recorded
Phase 37 trials
Phase 3 NCT07070752 Comparator Apr → Nov 2023 type 1 diabetes mellitus Geropharm Completed No outcome recorded
Phase 3 NCT04974528 Comparator Sep 2021 → Oct 2024 type 1 diabetes mellitus, type 2 diabetes mellitus Mannkind Corporation Completed No outcome recorded
Phase 3 NCT03529123 Background Jun 2018 → Nov 2019 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT01768559 Comparator Jan 2013 → Dec 2014 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 3 NCT01792830 Comparator Oct 2012 → Feb 2014 glucose metabolism disease Emory University Completed No outcome recorded
Phase 419 trials
Phase 4 NCT04196231 Comparator Nov 2019 → Sep 2020 type 2 diabetes mellitus University of Campania Luigi Vanvitelli Completed No outcome recorded
Phase 4 NCT04124302 Background Oct 2019 → Mar 2024 type 1 diabetes mellitus Medical University of Warsaw Completed No outcome recorded
Phase 4 NCT03359837 Background Jan 2018 → Jun 2020 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 4 NCT03260868 Background Sep 2017 → Nov 2018 type 1 diabetes mellitus Sanofi Terminated No outcome recorded
Phase 4 NCT03013985 Background May 2017 → Mar 2019 type 2 diabetes mellitus Emory University Completed No outcome recorded
Phase not applicable5 trials
NCT04965051 Comparator Aug 2021 → Dec 2023 type 1 diabetes mellitus Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
NCT01621776 Comparator Jun 2011 → Aug 2012 type 1 diabetes mellitus University of Florida Completed No outcome recorded
NCT01855243 Comparator Mar 2010 → Feb 2014 type 2 diabetes mellitus Cairo University Completed No outcome recorded
NCT00528918 Comparator Jun 2007 → May 2011 type 2 diabetes mellitus Carl T. Hayden VA Medical Center Completed No outcome recorded
NCT00927524 Comparator Apr 2005 → Apr 2006 type 1 diabetes mellitus Vanderbilt University Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 110 sources stand behind the page.

FieldValueCited text
Known as Insulin Glulisine “Multicenter, Open, Non-Randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes...” NCT00546702
77

“Beginning 24 hours after maintenance of oral or enteral feedings patients receive an intensive regimen of insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4...” NCT00943709

“Multiple daily injections which consist of a single injection of basal insulin(insulin Glargine) and 3 injections of bolus insulin(rapid acting insulin Glulisine or Aspart)” NCT03112538

“Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening.” NCT02688933

“Individualized dose of RAA injection (insulin aspart, insulin lispro or insulin glulisine) for each patient for 26 weeks.” NCT04974528

“supporting its use as a biosimilar insulin glulisinePMID 41366610 Dec 2025

Insulin Glulisine (HMR1964) Injected Subcutaneously” NCT00545337

“insulin glargine insulin glulisineNCT00474838

“Apidra (insulin glulisine)” NCT00979628

NCT00397553

NCT01194258

NCT00174642

NCT00135096

NCT02276859

NCT01203111

NCT01131052

NCT02276196

NCT00539448

NCT01500850

NCT00310297

NCT00283049

NCT00969592

NCT00965549

NCT00272064

NCT02503501

NCT01081938

NCT02685449

NCT01212913

NCT04124302

NCT00174668

NCT00135057

NCT01121835

NCT00360698

NCT04019821

NCT00489190

NCT01768559

NCT01594060

NCT01122979

NCT00913497

NCT01234597

NCT01678235

NCT00670228

NCT00927524

NCT03359837

NCT01662921

NCT01159353

NCT01204593

NCT00046150

NCT01079364

NCT00290043

NCT00526513

NCT00115570

NCT00272012

NCT00290927

NCT00135083

NCT01194245

NCT00979875

NCT00964574

NCT00135941

NCT01417897

NCT01848990

NCT00368394

NCT00384085

NCT00271284

NCT00824668

NCT00596687

NCT00467649

NCT00297583

NCT00311077

NCT01436045

NCT00467376

NCT00290979

NCT00467636

NCT00607087

NCT00562133

NCT01013571

NCT01202474

NCT03529123

Known as Apidra “This study will compare how well regular insulin will compare to glargine (Lantus®) once daily plus glulisine (Apidra®) insulin before meals in hospitalized patients with type...” NCT00394407
24

“Beginning 24 hours after maintenance of oral or enteral feedings patients receive an intensive regimen of insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4...” NCT00943709

“Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects” NCT00311077

“pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.” NCT00135096

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).” NCT02798250

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02490098

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02626936

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846857

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846831

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02488616

“rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])” NCT00467649

“Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner” NCT02333851

“the patient receive continuous rapid insulin (APIDRA ®)with an external pump.” NCT01889914

“Levemir/Lantus/Tresiba plus NovoLog/Humalog/ApidraNCT04965051

“glargine (Lantus) + glulisine (Apidra)” NCT00590044

“Drug: Apidra (insulin glulisine)” NCT01013571

“Insulin Glulisine (Apidra)” NCT00670228

Apidra glulisine (HMR1964)” NCT00489190

“Glulisine (Apidra)” NCT00528918

“(Apidra®)” NCT00913497

NCT02048189

NCT03328845

NCT02914886

NCT01621776

NCT03260868

Known as Apidra (insulin glulisine) Apidra (insulin glulisine)NCT00979628
Known as glulisine “Patients were randomized to receive a premixed human insulin formulation with 70% intermediate insulin plus 30% regular insulin (Mixtard 30®, Novo Nordisk) or a basal-bolus...” NCT02333851
22

“The rapid-acting insulin analogue insulin glulisine (glulisine) was compared with insulin lispro (lispro) for efficacy and safety in Japanese patients with type 1 diabetes...” PMID 19614947 Jul 2009

“The short acting insulin analogue (lispro, aspart or glulisine) will be started at the dosage of 4 units before meals (3 times per day)” NCT04196231

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).” NCT02798250

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846857

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02488616

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02490098

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02626936

“Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)” NCT02846831

“A weight-based basal bolus insulin regimen starting with 0.1 units/kg/day of Glargine and 4 units/meal of Glulisine.” NCT01087567

“To evaluate the safety and efficacy of insulin glulisine (glulisine) with and without oral antidiabetic drugs” PMID 19614946 Jul 2009

“Fast-acting meal time insulin (lispro, aspart or glulisine) will be added if glycemic goal is not achieved.” NCT01974544

“Prandial Insulins (aspart, glulisine or lispro).” NCT01524705

“Lispro, Aspart, glulisineNCT04157738

NCT02987751

NCT01855243

NCT02278913

NCT01143948

NCT00590044

NCT00394407

NCT00528918

NCT02432716

NCT01792830

Known as glulisine insulin ClinicalTrials.gov intervention name — accepted as the source's own label NCT00640991
1

NCT03013985

Known as HMR1964 “Evaluation of Efficacy and Safety of HMR1964 (Insulin Glulisine) in Subjects With Type 1 Diabetes Mellitus; Insulin Lispro Controlled, Open, Randomized, Parallel Group,...” NCT00290979
8

“Dose-Exposure-Response Relationship of Insulin Glulisine (HMR1964) in Subjects With Type 1 Diabetes Mellitus Assessed With the Euglycemic Clamp Technique Using the Biostator (TM)” NCT00368394

“insulin glulisine (HMR 1964)” NCT00545337

“insulin glulisine (HMR 1964)” NCT00546702

“Insulin Glulisine (HMR1964)” NCT03529123

“Insulin glulisine (HMR1964)” NCT00046150

“INSULIN GLULISINE (HMR1964)” NCT00964574

“INSULIN GLULISINE (HMR1964)” NCT01234597

“Apidra glulisine (HMR1964)” NCT00489190

Known as insulin, glulisine, Apidra insulin, glulisine, ApidraNCT02432716
Known as Insuline glulisine ClinicalTrials.gov intervention name — accepted as the source's own label NCT00545337
Modality Protein / enzyme biologic “The rapid-acting insulin analogue insulin glulisine” PMID 19614947 Jul 2009
Route Subcutaneous “Continuous Subcutaneous Insulin Infusion (CSII)” NCT00046150