Insulin glargine

The long-acting insulin class, which includes insulin glargine, do not appear much better than neutral protamine Hagedorn (NPH) insulin, but do have a greater cost, making them, as of 2010, not cost effective for the treatment of type2 diabetes. 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, 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. However, a 2004 study found that mixing glargine with other insulins did not affect short-term glycemic profile. ==Adverse effects==

Common side effects include low blood sugar, problems at the site of injection, itchiness, and weight gain. Previous studies had raised concerns. 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. ==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. The admission was prolonged on 9 June 2005. A three-fold more concentrated formulation, brand name Toujeo, was introduced after FDA approval in 2015. == 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. Lusduna (Merck Sharp & Dohme (MSD)) was authorized for medical use in the European Union in January 2017. Semglee (Mylan and Biocon Biologics) was authorized for medical use in the European Union in March 2018. 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. Ondibta is a biosimilar medicinal product that is highly similar to the reference product Lantus, which was authorized in the EU in June 2000. Patent expiry Patent protection for insulin glargine expired in the European Union and the United States in 2014. 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)., Lantus, and Toujeo. == References ==