Drugs / Insulin glulisine
last change Dec 2025 re-read 9 days ago

Insulin glulisine

Protein / enzyme biologic

Developed for
type 2 diabetes mellitus · type 1 diabetes mellitus · diabetes mellitus · hyperglycemia · Alzheimer disease · chronic obstructive pulmonary disease · cognitive impairment with or without cerebellar ataxia · diabetic ketoacidosis
+4 more · Down syndrome · localized lipodystrophy · 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
+25 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 · 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 66 · started per year

today
US approved 2004
EU approved 2004
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20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials · 1 met primary
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 Met primary
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 NCT00297583 Apr → May 2004 type 1 diabetes mellitus Sanofi Completed No outcome recorded
Phase 1 NCT00311077 Apr → Oct 2004 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 · 1 met primary
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 Met primary
Phase 318 trials · 4 met primary
Phase 3 NCT00943709 May 2009 → Mar 2010 hyperglycemia, leukemia University of Medicine and Dentistry of New Jersey Withdrawn No outcome recorded Stop: Enrollment
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 Met primary
Phase 3 NCT00174668 Nov 2004 → Nov 2007 type 2 diabetes mellitus Sanofi Completed No outcome recorded
Phase 435 trials · 5 met primary · 2 missed
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 Met primary
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 Met primary
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 Stop: Enrollment
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 Stop: Enrollment
Comparator or background therapy40 trials
Phase 1 NCT00969592 Comparator Nov → Dec 2007 diabetes mellitus Profil Institute for Metabolic Research GmbH Completed No outcome recorded
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 Stop: Business
Phase 2 NCT02798250 Comparator Jun 2016 → Mar 2017 type 1 diabetes mellitus Montreal Clinical Research Institute Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2010-06-28 Halozyme Therapeutics Results Coinjection of Halozyme's rHuPH20 Enzyme Accelerates the Absorption and Action of Mealtime Insulin Analogs halozyme.com ↗
The coinjection of PH20 with lispro (Humalog(R)), aspart (NovoLog(R)) and glulisine (Apidra(R)) results in a more physiologic fast-in, fast-out profile and enhances the glucodynamic performance for each analog.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 108 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 glulisine” PMID 41366610 ↗ Dec 2025

“Insulin Glulisine (HMR1964) Injected Subcutaneously” NCT00545337 ↗

“insulin glargine insulin glulisine” NCT00474838 ↗

“Apidra (insulin glulisine)” NCT00979628 ↗

NCT01212913 ↗

NCT02276196 ↗

Show 67 more sources

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)” NCT02846831 ↗

“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)” NCT02488616 ↗

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

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

Show 14 more sources

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)” NCT02626936 ↗

“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)” 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)” 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

Show 12 more sources

Known as HMR1964 “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 ↗
8

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

“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 (HMR1964)” NCT00964574 ↗

“Insulin glulisine (HMR1964)” NCT00046150 ↗

“INSULIN GLULISINE (HMR1964)” NCT01234597 ↗

“Insulin Glulisine (HMR1964)” NCT03529123 ↗

“Apidra glulisine (HMR1964)” NCT00489190 ↗

Known as insulin, glulisine, Apidra “insulin, glulisine, Apidra” NCT02432716 ↗
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 ↗