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Insulin glargine

Insulin glargine sold, among others, under the brand name Lantus (manufactured and marketed by Sanofi) is a long-acting modified form of medical insulin, used in the management of type1 and type2 diabetes. It is injected just under the skin. Effects generally begin an hour after use.

Common side effects include low blood sugar, problems at the site of injection, itchiness, and weight gain. Other serious side effects include low blood potassium. NPH insulin rather than insulin glargine is generally preferred in pregnancy.[8] After injection, microcrystals slowly release insulin for about 24 hours. This insulin causes body tissues to absorb glucose from the blood and decreases glucose production by the liver.

Insulin glargine was patented, but the patent expired in most jurisdictions in 2014. It was approved for medical use in the United States in 2000.[9] It is on the World Health Organization's List of Essential Medicines.[10] In 2023, it was the 30th most commonly prescribed medication in the United States, with more than 18million prescriptions.[11][12] In July 2021, the US Food and Drug Administration (FDA) approved an interchangeable biosimilar insulin product called Semglee (insulin glargine-yfgn) for the treatment of diabetes.[13]

Medical uses

The long-acting insulin class, which includes insulin glargine, do not appear much better than neutral protamine Hagedorn (NPH) insulin,[14] but do have a greater cost, making them, as of 2010, not cost effective for the treatment of type2 diabetes.[15] In a previous review it was unclear if there is a difference in hypoglycemia, as there was not enough data to determine any differences with respect to long term outcomes,[16] however a more recent Cochrane systematic review did not find clinically significant difference when comparing insulin glargine to NPH insulin, insulin detemir or insulin degludec in the management of type1 diabetes in either adults or children over periods of 6 months or longer.[14] It is not typically the recommended long-acting insulin in the United Kingdom.[8]

Semglee is indicated to improve glycemic control in adults and children with type1 diabetes and in adults with type2 diabetes.[13] Semglee is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine), a long-acting insulin analog.[13]

Mixing with other insulins

The American Diabetes Association said in 2003 that, unlike some other longer-acting insulins, glargine should not be diluted or mixed with other insulin or solution in the same syringe, due to the low pH of its diluent.[17] However, a 2004 study found that mixing glargine with other insulins did not affect short-term glycemic profile.[18]

Adverse effects

Common side effects include low blood sugar, problems at the site of injection, itchiness, and weight gain.[9] Serious side effects include low blood potassium.[9]

As of 2012, tentative evidence shows no association between insulin glargine and cancer.[19] Previous studies had raised concerns.[20]

When comparing insulin glargine to NPH insulin, insulin detemir or insulin degludec, no significant adverse effects were found in the management of type1 diabetes in either adults or children in periods of six months or longer.[14]

Pharmacology

Mechanism of action

Insulin glargine differs from human insulin by replacing asparagine with glycine in position 21 of the A-chain and by carboxy-terminal extension of B-chain by 2 arginine residues. The arginine amino acids shift the isoelectric point from a pH of 5.4 to 6.7, making the molecule more soluble at an acidic pH and less soluble at physiological pH. The isoelectric shift also allows for the subcutaneous injection of a clear solution. The glycine substitution prevents deamidation of the acid-sensitive asparagine at acidic pH. In the neutral subcutaneous space, higher-order aggregates form, resulting in a slow, peakless dissolution and absorption of insulin from the site of injection.[21]

History

In June 2000, the European Commission formally approved the launching of Lantus by Sanofi-Aventis Germany in the European Union.[22] The admission was prolonged on 9 June 2005.[23]

A three-fold more concentrated formulation, brand name Toujeo, was introduced after FDA approval in 2015.[24][25]

Legal status

Biosimilars

Semglee (glargine-yfgn) received US Food and Drug Administration (FDA) approval in July 2021. The approval was granted to Mylan, which had merged with Upjohn into Viatris.

Rezvoglar (glargine-aglr) was approved by the FDA in December 2021 to be produced by Lilly.

Abasaglar (Eli Lilly and Boehringer Ingelheim) was authorized for medical use in the European Union in September 2014.[26][27]

Lusduna (Merck Sharp & Dohme (MSD)) was authorized for medical use in the European Union in January 2017.[28]

Semglee (Mylan and Biocon Biologics) was authorized for medical use in the European Union in March 2018.[29]

In November 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ondibta, intended for the treatment of diabetes. The applicant for this medicinal product is Gan & Lee Pharmaceuticals Europe GmbH.[30] Ondibta is a biosimilar medicinal product that is highly similar to the reference product Lantus, which was authorized in the EU in June 2000.[30] Ondibta was authorized for medical use in the European Union in January 2026.[30][31]

Patent expiry

Patent protection for insulin glargine expired in the European Union and the United States in 2014.[32] Insulin glargine from competitor Eli Lilly became available in most countries during 2015, under the brand names Basaglar (as a follow-on in the US) and Abasaglar (as a biosimilar in the EU).[32]

Brand names

Insulin glargine is sold under various brand names including Basaglar[33], Lantus[34], and Toujeo[35].

References

  1. Insulin glargine Use During Pregnancy Drugs.com, 6 April 2020, retrieved 4 September 2020^
  2. Summary Basis of Decision - Semglee Health Canada, 23 August 2022, retrieved 29 September 2022^
  3. Lantus Product information Health Canada, 23 October 2007, retrieved 16 February 2026^
  4. Lantus 100 units/ml solution for injection in a cartridge - Summary of Product Characteristics (SmPC) (emc), retrieved 7 May 2020^
  5. Lantus- insulin glargine injection, solution Lantus SoloStar- insulin glargine injection, solution DailyMed, retrieved 29 July 2021^
  6. Lantus EPAR European Medicines Agency (EMA), 8 May 2009, retrieved 28 July 2021^
  7. Toujeo EPAR European Medicines Agency (EMA), 11 May 2009, retrieved 28 July 2021^
  8. British national formulary: BNF 76 Pharmaceutical Press, 2018^
  9. Insulin Glargine Monograph for Professionals Drugs.com, AHFS, retrieved 23 December 2018^
  10. The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list World Health Organization, 2025^
  11. Top 300 of 2023 ClinCalc, retrieved 12 August 2025^
  12. Insulin Glargine Drug Usage Statistics, United States, 2014 - 2023 ClinCalc, retrieved 13 August 2025^
  13. FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes U.S. Food and Drug Administration (FDA), 28 July 2021, retrieved 28 July 2021^
  14. (Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus The Cochrane Database of Systematic Reviews, March 2021^
  15. Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation Health Technology Assessment, July 2010^
  16. Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis CMAJ, February 2009^
  17. American Diabetes Association. Insulin administration Diabetes Care, January 2003^
  18. Effects of mixing glargine and short-acting insulin analogs on glucose control Diabetes Care, November 2004^
  19. Insulin glargine and cancer risk in patients with diabetes: a meta-analysis PLOS ONE, 2012^
  20. Glargine safety, diabetes and cancer Expert Opinion on Drug Safety, March 2013^
  21. Insulin analogues and their potential in the management of diabetes mellitus Diabetologia, October 1999^
  22. Lantus EPAR European Medicines Agency (EMA), 8 May 2009, retrieved 7 May 2020^
  23. EPAR Lantus, German summary of admission report of the European Medicines Agency (PDF)^
  24. Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo Sanofi, 25 February 2015^
  25. Drug Approval Package: Toujeo (Insulin Glargine) Injection U.S. Food and Drug Administration (FDA), 2 March 2016, retrieved 16 February 2026^
  26. Abasaglar EPAR European Medicines Agency (EMA), 14 October 2014, retrieved 28 July 2021^
  27. Abasaglar Product information Union Register of medicinal products, 11 September 2014, retrieved 1 October 2023^
  28. Lusduna EPAR European Medicines Agency (EMA), 12 January 2017, retrieved 28 July 2021^
  29. Semglee EPAR European Medicines Agency (EMA), 23 May 2018, retrieved 28 July 2021^
  30. Ondibta European Medicines Agency (EMA), 14 November 2025, retrieved 16 February 2026^
  31. Ondibta Product information Union Register of medicinal products, 9 January 2026, retrieved 16 February 2026^
  32. Biosimilars of insulin glargine GaBI Generics and Biosimilars Initiative, 27 November 2020^
  33. Basaglar (insulin glargine) injection Eli Lilly and Company, retrieved 2026-03-07^
  34. Lantus (insulin glargine injection) 100 Units/mL Lantus, retrieved 2026-03-07^
  35. Toujeo U-300 (insulin glargine) injection, for subcutaneous use Prescribing Information Sanofi, retrieved 2026-03-07^