Insulin glargine sold, among others, under the brand name Lantus (manufactured and marketed by Sanofi) is a long-acting insulin analogue form of medical insulin, used in the management of type 1 and type 2 diabetes.[ It is injected just under the skin.][ Effects generally begin an hour after use.][
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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.][ This insulin causes body tissues to absorb glucose from the blood and decreases glucose production by the liver.][
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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.[ ]
Medical uses
The long-acting insulin class, which includes insulin glargine, do not appear much better than NPH insulin,[
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Semglee is indicated to improve glycemic control in adults and children with type 1 diabetes and in adults with type 2 diabetes.
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.
Adverse effects
Common side effects include low blood sugar, problems at the site of injection, itchiness, and weight gain.[ Serious side effects include low blood potassium.][
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As of 2012, tentative evidence shows no association between insulin glargine and cancer.
When comparing insulin glargine to NPH insulin, insulin detemir or insulin degludec, no significant adverse effects were found in the management of type 1 diabetes in either adults or children in periods of six months or longer.
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.
History
In June 2000, the European Commission formally approved the launching of Lantus by Sanofi-Aventis Germany in the European Union.[ EPAR Lantus , German summary of admission report of the European Medicines Agency (PDF)]
A three-fold more concentrated formulation, brand name Toujeo, was introduced after FDA approval in 2015.
Legal status
Biosimilars
As of 2025, there are two commercially available insulin glargine biosimilars in the USA:
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Semglee (glargine-yfgn) received FDA approval in July 2021. The approval was granted to Mylan, which had merged with Upjohn into Viatris in 2020.
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Rezvoglar (glargine-aglr) was approved by the FDA in December 2021 to be produced by Lilly.
Europe was much earlier with approving Insulin glargine biosimilars:
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Abasaglar (Eli Lilly and Boehringer Ingelheim) was approved for medical use in the European Union in September 2014
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Lusduna (Merck Sharp & Dohme (MSD), which is the name under which Merck operates outside of the U.S. and Canada) was approved for medical use in the European Union in January 2017.
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Semglee (Mylan and Biocon Biologics) was approved for medical use in the European Union in March 2018.
Patent expiry
Patent protection for insulin glargine expired in Europe and the US in 2014.[
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Brand names
Insulin glargine is available under brand names including Basaglar, Lantus, and Toujeo.
