Drugs / regular insulin
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regular insulin

Protein / enzyme biologic

Developed for
type 1 diabetes mellitus · type 2 diabetes mellitus · diabetes mellitus · hyperglycemia · acute coronary syndrome · cognitive impairment with or without cerebellar ataxia · delirium · Alzheimer disease
+20 more · atypical depressive disorder · bipolar disorder · cirrhosis of liver · critical illness polyneuropathy · dry eye syndrome · gestational diabetes · infectious disease with sepsis · intermediate coronary syndrome · major depressive disorder · myocardial infarction · Parkinson disease · skin atrophy · spinal cord injury · stroke disorder · subjective cognitive decline · ulcer of lower limbs · corneal disorder · diabetic ketoacidosis · ischemic stroke · peripheral vascular disease
Investigated by
Mannkind Corporation · Pfizer · HealthPartners Institute · Columbia University · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Novo Nordisk A/S
+64 more · Albert Einstein College of Medicine · Congressionally Directed Medical Research Programs · Halozyme Therapeutics · Jaeb Center for Health Research · Karolinska Institutet · Sanofi · Stanford University · Uniformed Services University of the Health Sciences · Aarhus University Hospital · Arecor Limited · Assiut University · B. Braun Melsungen AG · Danish Research Centre for Magnetic Resonance · DexCom, Inc. · Diabetes and Glandular Disease Clinic · Emory University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Fundación Pública Andaluza Progreso y Salud · German Federal Ministry of Education and Research · Greet Van den Berghe · HemoCue · Hiroaki Sato, MD., PhD. · Innovative Diabetes Treatment Studies LLC. · International Diabetes Center at Park Nicollet · James A. Haley Veterans Administration Hospital · Jinnah Postgraduate Medical Centre · Juvenile Diabetes Research Foundation · Khyber Teaching Hospital · Maya Guglin · McGill University Health Centre/Research Institute of the McGill University Health Centre · Medical University of Graz · Medtronic · Model Clinical Research LLC · National Heart, Lung, and Blood Institute (NHLBI) · National Institute on Aging (NIA) · Nordsjaellands Hospital · Odense University Hospital · Profil Institute for Metabolic Research GmbH · Regionshospitalet Silkeborg · Riverside University Health System Medical Center · Sam Chun Dang Pharm. Co. Ltd. · Sciema UG · SepNet - Critical Care Trials Group · St George's, University of London · Steno Diabetes Center Copenhagen · Sunnybrook Health Sciences Centre · Tufts Medical Center · Universidade Positivo · University Health Network, Toronto · University of Aarhus · University of Alabama at Birmingham · University of California, Berkeley · University of Campania Luigi Vanvitelli · University of Copenhagen · University of Jena · University of North Carolina, Chapel Hill · University of Pittsburgh · University of Roma La Sapienza · University of South Florida · University of Washington · Wake Forest University Health Sciences · WakeMed Health and Hospitals · Xeris Pharmaceuticals · Yonsei University

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) AFREZZA — 2017-09-29 – 2026-05-29 fda.gov ↗
Refused (EMA) EU (EMA) Solumarv — 2016-02-11 europa.eu ↗
Label expansions (2) US (FDA) HUMULIN R PEN — 1994-03-31 – 2011-03-25 fda.gov ↗
Approved EU (EMA) Insuman — 1997-02-21 europa.eu ↗
Approved US (FDA) HUMULIN R PEN — 1982-10-28 fda.gov ↗

Trials 63 · started per year

today
US approved 1982
EU approved 1997
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials · 1 met primary
Phase 1 NCT06558422 Jan 2027 → Dec 2028 expected hyperinsulinism, metabolic dysfunction-associated steatotic liver disease, obesity disorder, prediabetes syndrome Columbia University Not yet recruiting No outcome recorded
Phase 1 NCT07634770 May → Oct 2026 expected type 1 diabetes mellitus Sam Chun Dang Pharm. Co. Ltd. Recruiting No outcome recorded
Phase 1 NCT07384052 Feb → Aug 2026 overdue spinal cord injury HealthPartners Institute Recruiting No outcome recorded
Phase 1 NCT07090824 Oct 2025 → May 2026 type 1 diabetes mellitus Stanford University Completed No outcome recorded
Phase 1 NCT06434038 Aug 2025 → Feb 2026 — HealthPartners Institute Withdrawn No outcome recorded
Phase 1 NCT06126354 Jul 2024 → Nov 2025 NAFLD1, prediabetes syndrome Columbia University Withdrawn No outcome recorded
Phase 1 NCT05724134 Aug 2023 → Sep 2025 NAFLD1, hyperinsulinism, obesity disorder, prediabetes syndrome Columbia University Completed No outcome recorded
Phase 1 NCT05866367 Aug 2023 → Jun 2024 — HealthPartners Institute Terminated No outcome recorded Stop: Business
Phase 1 NCT05754424 Feb 2023 → Jan 2024 type 2 diabetes mellitus Arecor Limited Completed Met primary
Phase 1 NCT01269606 Jan → Mar 2011 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03915613 Oct 2021 → Oct 2024 atypical depressive disorder, bipolar disorder, major depressive disorder University Health Network, Toronto Unknown No outcome recorded
Phase 213 trials · 4 met primary
Phase 2 NCT06002854 Aug → Dec 2022 skin atrophy Jinnah Postgraduate Medical Centre Completed No outcome recorded
Phase 2 NCT04542148 Feb 2022 → Nov 2025 overdue gestational diabetes, type 2 diabetes mellitus University of Alabama at Birmingham Active not recruiting No outcome recorded
Phase 2 NCT04199767 Jul → Nov 2020 cognitive disorder, cognitive impairment with or without cerebellar ataxia Wake Forest University Health Sciences Completed No outcome recorded
Phase 2 NCT04251585 Feb 2020 → Aug 2024 Parkinson disease HealthPartners Institute Completed No outcome recorded
Phase 2 NCT04028960 Oct 2019 → Apr 2020 type 1 diabetes mellitus HealthPartners Institute Terminated No outcome recorded Stop: Business
Phase 2 NCT04074317 Aug 2019 → Apr 2020 type 1 diabetes mellitus Xeris Pharmaceuticals Completed Met primary
Phase 2 NCT02527265 Sep 2017 → Mar 2020 type 1 diabetes mellitus Mannkind Corporation Completed No outcome recorded
Phase 2 NCT02028078 Jan 2014 → Mar 2016 type 1 diabetes mellitus Medical University of Graz Completed No outcome recorded
Phase 2 NCT00774800 Oct 2008 → Mar 2009 type 1 diabetes mellitus Halozyme Therapeutics Completed Met primary
Phase 2 NCT00835861 Aug 2008 → Feb 2010 pregnancy disorder, type 2 diabetes mellitus University of North Carolina, Chapel Hill Completed No outcome recorded
Phase 311 trials · 2 met primary · 3 missed
Phase 3 NCT04974528 Sep 2021 → Oct 2024 type 1 diabetes mellitus, type 2 diabetes mellitus Mannkind Corporation Completed Met primary
Phase 3 NCT03324776 Oct 2017 → Jun 2020 type 2 diabetes mellitus Model Clinical Research LLC Completed No outcome recorded
Phase 3 NCT00479258 Oct 2007 type 1 diabetes mellitus Pfizer Terminated No outcome recorded
Phase 3 NCT00091507 Nov 2006 → Aug 2011 congestive heart failure, intermediate coronary syndrome, myocardial infarction Tufts Medical Center Completed Missed primary
Phase 3 NCT00348374 Jun 2006 → Aug 2008 type 2 diabetes mellitus Pfizer Completed No outcome recorded
Phase 3 NCT00440284 Jan → Dec 2004 type 2 diabetes mellitus University of Jena Unknown Met primary
Phase 3 NCT00135473 Apr 2003 → Sep 2005 infectious disease with sepsis SepNet - Critical Care Trials Group Completed Missed primary
Phase 3 NCT00139659 Jan 2003 → Oct 2008 asthma, diabetes mellitus Pfizer Completed No outcome recorded
Phase 3 NCT00150410 Jan 2003 → Jun 2007 diabetes mellitus Pfizer Completed No outcome recorded
Phase 3 NCT00071448 Jun 2002 → Jun 2004 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 416 trials · 3 met primary
Phase 4 NCT06939959 Apr 2025 → Jan 2026 overdue dry eye syndrome Khyber Teaching Hospital Recruiting No outcome recorded
Phase 4 NCT05904743 Jul 2023 → Mar 2024 type 1 diabetes mellitus Mannkind Corporation Completed No outcome recorded
Phase 4 NCT05243628 Mar → Oct 2022 type 1 diabetes mellitus Mannkind Corporation Completed No outcome recorded
Phase 4 NCT04849845 Apr → May 2021 type 1 diabetes mellitus, type 2 diabetes mellitus Mannkind Corporation Completed No outcome recorded
Phase 4 NCT04030091 Sep 2019 → Oct 2020 type 1 diabetes mellitus, type 2 diabetes mellitus Sciema UG Completed No outcome recorded
Phase 4 NCT04125082 Feb 2019 → Mar 2020 type 2 diabetes mellitus Diabetes and Glandular Disease Clinic Unknown No outcome recorded
Phase 4 NCT02706119 Jul 2016 → Mar 2018 diabetes mellitus Fundación Pública Andaluza Progreso y Salud Completed No outcome recorded
Phase 4 NCT02189395 Apr 2013 → Apr 2017 type 2 diabetes mellitus Riverside University Health System Medical Center Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT02165566 Mar 2013 → Mar 2014 hyperglycemia University of Roma La Sapienza Completed Met primary
Phase 4 NCT01151176 Aug 2012 → Aug 2013 acute coronary syndrome Universidade Positivo Suspended No outcome recorded
Phase not applicable11 trials · 1 missed
— NCT03324867 Apr 2022 → Apr 2023 delirium, heart disorder, subjective cognitive decline McGill University Health Centre/Research Institute of the McGill University Health Centre Unknown No outcome recorded
— NCT03415061 Nov 2021 → Nov 2023 delirium, heart disorder Hiroaki Sato, MD., PhD. Unknown No outcome recorded
— NCT05095259 Dec 2019 → Dec 2023 type 1 diabetes mellitus Nordsjaellands Hospital Unknown No outcome recorded
— NCT02694289 Nov 2016 → Sep 2018 type 2 diabetes mellitus Maya Guglin Withdrawn No outcome recorded Stop: Enrollment
— NCT04726631 Jan 2015 → Sep 2019 diabetes mellitus Assiut University Completed No outcome recorded
— NCT01307306 Mar 2011 → Mar 2018 — Sunnybrook Health Sciences Centre Completed No outcome recorded
— NCT01831154 May 2010 → Jul 2011 diabetes mellitus, hyperglycemia James A. Haley Veterans Administration Hospital Completed Mixed
— NCT00654056 Mar 2008 → Oct 2009 type 2 diabetes mellitus University of Aarhus Completed No outcome recorded
— NCT00240149 Oct 2005 → Mar 2006 hyperglycemia Stanford University Completed No outcome recorded
— NCT01957930 Jan 1984 → Dec 2011 ulcer of lower limbs Karolinska Institutet Completed No outcome recorded
Comparator or background therapy52 trials
Phase 1 NCT07364669 Comparator Oct 2024 → Feb 2025 — Laboratorios PiSA Completed No outcome recorded
Phase 1 NCT04022317 Comparator Jun → Sep 2019 — Biocon Limited Completed No outcome recorded
Phase 1 NCT03916640 Comparator Jan → Mar 2019 type 1 diabetes mellitus Adocia Completed No outcome recorded
Phase 1 NCT02500979 Background Aug 2015 → Aug 2016 type 1 diabetes mellitus AstraZeneca Completed Met primary
Phase 1 NCT01581736 Background Apr 2012 → Apr 2016 obesity disorder, type 2 diabetes mellitus Mayo Clinic Terminated No outcome recorded

Press releases naming this drug 236 releases

DateIssuerRelease
2026-07-30 Arecor Limited Diabetes, Obesity and Metabolism article – A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI arecor.com ↗
2026-06-23 Mannkind Corporation MannKind Awarded Breakthrough T1D Grant to Support Advancement of INHALE-1ST Pediatric Trial of Afrezza® in Youth with Newly-Diagnosed T1D mannkindcorp.com ↗
2026-06-06 DexCom, Inc. Dexcom CONNECT Study: The Most Significant Clinical Study Demonstrating CGM Benefits for People with Type 2 Diabetes Not Using Insulin dexcom.com ↗
2026-06-05 Mannkind Corporation Data at ADA 2026 Highlights Key Findings from Clinical and Real‑World Studies of MannKind’s Afrezza® (Inhaled Insulin) Across Pediatric Care, Pregnancy, and Use with Automated Insulin Delivery (AID) Systems mannkindcorp.com ↗
2026-05-29 Mannkind Corporation MannKind to Host Conference Call Today to Discuss Afrezza Pediatric Approval mannkindcorp.com ↗
2026-05-29 Mannkind Corporation MannKind Announces FDA Approval of Afrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes mannkindcorp.com ↗
2026-05-27 Mannkind Corporation MannKind to Showcase New Data at ADA 2026 Advancing Understanding of Inhaled Insulin (Afrezza®) in Pediatric Care, Pregnancy and Use with Automated Insulin Delivery (AID) Systems mannkindcorp.com ↗
2026-03-26 Novo Nordisk A/S Novo Nordisk A/S: Awiqli® approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes novonordisk.com ↗
2026-03-09 Mannkind Corporation MannKind to Present New Data From Pediatric and Adult Studies of Afrezza® at ATTD 2026 mannkindcorp.com ↗
2026-02-09 Mannkind Corporation MannKind Announces First Patient Enrolled in INHALE-1ST Pediatric Study Evaluating Afrezza® for Youth with Newly-Diagnosed Type 1 Diabetes (T1D) mannkindcorp.com ↗
2026-01-26 Mannkind Corporation MannKind Announces FDA Approval of Updated Afrezza® Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy mannkindcorp.com ↗
2025-11-19 DexCom, Inc. Dexcom Smart Basal Receives FDA Clearance Becoming the First and Only CGM-integrated Basal Insulin Dosing Optimizer for Type 2 Diabetes dexcom.com ↗
Show all 236 releases opens the full record — a long page

Evidence & citations 29 cited values

Every value below carries the sentence it was read from. 119 sources stand behind the page.

FieldValueCited text
Known as Regular insulin “bolus of 1-3 IU/kg regular insulin together with 0.5-1 gm/kg dextrose followed by an intravenous infusion of 0.2 to 1 IU/kg/hr of regular insulin and a dextrose infusion will...” NCT07451561 ↗
56

“Continuous intravenous regular insulin infusion will be adjusted to maintain glycemic levels at least below 150 mg/dl, and, in stable patients and ideally, between 80 and 120 mg/dl.” NCT00747279 ↗

“Commercially available U-500 Humulin (regular insulin) diluted 1:4 with dilution buffer composed of sterile water, EDTA and mannitol to achieve U-100 concentration.” NCT07090824 ↗

“three administrations of regular insulin or short acting insulin analogues before meals combined with long-acting insulin analogue glargine in the evening.” NCT01150617 ↗

“Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.” NCT04199767 ↗

“glucose-insulin-potassium (GIK) consists of 20% glucose (200 g/L), 66.7 U/L regular insulin and 80 mmol/L potassium chloride (KCl).” NCT01516138 ↗

“CIT consisted of twice daily injections of premixed insulin (30% regular insulin, 70% NPH-insulin) before breakfast and dinner.” NCT00440284 ↗

“Regular insulin (Novolin-R) 20 international units (10 units) in one nostril twice daily for 21 days, 100 µl volume.” NCT04251585 ↗

“Participants will continue with current mixed insulin treatment using NPH , or lente, and regular insulin .” NCT01424046 ↗

“Human insulin: NPH and regular insulin: 2/3 of total daily dose as NPH and 1/3 as regular insulin.” NCT02278913 ↗

“Regular insulin subcutaneously wil be given in three equally divided doses before each meal.” NCT02758522 ↗

Show 46 more sources

Known as Actrapid “Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day” NCT01957930 ↗
14

“Actrapid: subcutaneous insulin/ Placebo A high dose (oral)” NCT07634770 ↗

“Insulatard, Actrapid, Lantus, monotard” NCT00506194 ↗

“Intravenous insulin (actrapid)” NCT00764556 ↗

“Mealtime insulin (Actrapid)” NCT02138006 ↗

NCT00145353 ↗

NCT00135473 ↗

NCT00752180 ↗

NCT00653510 ↗

NCT00654056 ↗

NCT02933645 ↗

Show 4 more sources

Known as Afrezza “Afrezza (insulin human) Inhalation Powder” NCT05243628 ↗
7

NCT05904743 ↗

NCT04849845 ↗

NCT02527265 ↗

NCT04974528 ↗

NCT04125082 ↗

NCT03313960 ↗

NCT03324776 ↗

Known as Exubera “Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin” NCT00139659 ↗
6

“Exubera® (Insulin Dry Powder Pulmonary Inhaler)” NCT00150410 ↗

“The drug is called EXUBERA (inhaled insulin).” NCT00137046 ↗

NCT00315952 ↗

NCT00479258 ↗

NCT00418522 ↗

NCT00348374 ↗

Known as fast-acting insulin human “At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.” NCT01269606 ↗
Known as Hlin “The aim of this multicenter, prospective, randomized, crossover trial is to compare, in critical care patients receiving insulin infusion therapy (IIT), the pharmacodynamic of...” PMID 25466315 ↗ Oct 2014
Known as HR1799 “Insulin human/Insuman Comb 25 (HR1799)” NCT01353469 ↗
1

“insulin human (HR1799)” NCT01630369 ↗

Known as human insulin “a total of 16 sprays or 160 IU of fast-acting human insulin (Actrapid, Novo Nordisk A/S, Bagsvaerd, Denmark).” NCT02933645 ↗
2

“Actrapid (human insulin)” NCT00653510 ↗

“Actrapid (human insulin)” NCT00654056 ↗

Known as Humulin “Commercially available U-500 Humulin (regular insulin) diluted 1:4 with dilution buffer composed of sterile water, EDTA and mannitol to achieve U-100 concentration.” NCT07090824 ↗
5

“eg. Humulin, Lantus, Novalin” NCT02694289 ↗

“Regular Insulin (Humulin®)” NCT04074317 ↗

“Regular insulin (Humulin)” NCT00553488 ↗

NCT01581736 ↗

NCT03916640 ↗

Known as HumulinR “Humulin® R is a polypeptide hormone structurally identical to human insulin synthesised through recombinant deoxyribonucleic acid (rDNA) technology in a non-pathogenic...” NCT04022317 ↗
13

“Types of insulin: insulin lispro (Humalog 100 IU/mL) as fast-acting insulin and regular insulin (Humulin R) as regular insulin (Eli Lilly and Company, Indianapolis, IN, USA).” NCT04783376 ↗

“Intranasal insulin will be made prepared from Humulin® R [insulin injection, human biosynthetic (rDNA Origin) REGULAR; 10 mL/vial, manufactured by Eli Lilly].” NCT03915613 ↗

“Regular insulin (Humulin-R), intranasal route” NCT04028960 ↗

“Humulin® R (regular insulin human)” NCT04022317 ↗

NCT00705536 ↗

NCT01307306 ↗

NCT05768191 ↗

NCT00916357 ↗

NCT04030091 ↗

NCT00774800 ↗

Show 3 more sources

Known as Inhaled Human Insulin “Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin” NCT00139659 ↗
Known as Inhaled Insulin “Inhaled Insulin (Exubera)” NCT00418522 ↗
Known as Insulin “Actrapid® (Insulin)” NCT00135473 ↗
Known as insulin human “Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.” NCT01850615 ↗
15

“At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.” NCT01269606 ↗

“The test product is defined as Afrezza [insulin human] inhalation powder administered using the Afrezza inhaler.” NCT04849845 ↗

NCT00071448 ↗

NCT06002854 ↗

NCT06126354 ↗

NCT05095259 ↗

NCT02028078 ↗

NCT01630369 ↗

NCT06558422 ↗

NCT01353469 ↗

Show 5 more sources

Known as insulin injection, human biosynthetic (rDNA Origin) REGULAR “Intranasal insulin will be made prepared from Humulin® R [insulin injection, human biosynthetic (rDNA Origin) REGULAR; 10 mL/vial, manufactured by Eli Lilly].” NCT03915613 ↗
Known as Insuman Comb 25 “Insulin human/Insuman Comb 25 (HR1799)” NCT01353469 ↗
Known as Novolin 30R “Insulin human/Novolin® 30R” NCT01353469 ↗
Known as Novolin-R “Regular insulin (Novolin-R) 20 international units (10 units) in one nostril twice daily for 21 days, 100 µl volume.” NCT04251585 ↗
1

“Regular Human Insulin (Novolin® R)” NCT00071448 ↗

Known as Recombinant Human Insulin “Actrapid, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml” NCT00719108 ↗
Known as Regular Human Insulin “regular human insulin was administered with pramlintide or placebo using separate infusion pumps in a fixed ratio (9 μg/unit).” PMID 30213882 ↗ Sep 2018
3

“10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals.” NCT05768191 ↗

“Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.” NCT05754424 ↗

“Regular Human Insulin (Novolin® R)” NCT00071448 ↗

Known as Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk “Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk” NCT02216799 ↗
Known as regular insulin human “Humulin® R (regular insulin human)” NCT04022317 ↗
1

NCT03415061 ↗

Known as Regular Novolin R “Regular Novolin R” NCT04251585 ↗
Known as RHI “regular human insulin (RHI)” PMID 21355716 ↗ Feb 2011
Known as sliding-scale regular insulin “receive sliding-scale regular insulin (SSRI) alone” PMID 19336639 ↗ Apr 2009