 Toujeo branded insulin glargine | |
| Clinical data | |
|---|---|
| Trade names | Lantus, others |
| Biosimilars | insulin glargine-aglr, insulin glargine-yfgn, Abasaglar, Rezvoglar, Semglee |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a600027 |
| License data | |
| Pregnancy category | |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Onset of action | ~1 hour[7] |
| Duration of action | 24–36 hours[7] |
| Identifiers | |
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| CAS Number | |
| IUPHAR/BPS | |
| DrugBank |
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| ChemSpider |
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| UNII | |
| KEGG |
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| CompTox Dashboard(EPA) | |
| ECHA InfoCard | 100.241.126 |
| Chemical and physical data | |
| Formula | C267H404N72O78S6 |
| Molar mass | 6062.96 g·mol−1 |
 N Y (what is this?) (verify) | |
Insulin glargine sold, among others, under the brand nameLantus (manufactured and marketed bySanofi) is a long-actingmodified form ofmedical insulin, used in the management oftype 1 andtype 2 diabetes.[7] It isinjected just under the skin.[7] Effects generally begin an hour after use.[7]
Common side effects includelow blood sugar, problems at the site of injection, itchiness, and weight gain.[7] Other serious side effects includelow blood potassium.[7]NPH insulin rather than insulin glargine is generally preferred inpregnancy.[8] After injection,microcrystals slowly release insulin for about 24 hours.[7] This insulin causes body tissues to absorbglucose from the blood and decreases glucose production by the liver.[7]
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.[7] It is on theWorld Health Organization's List of Essential Medicines.[9] In 2023, it was the 30th most commonly prescribed medication in the United States, with more than 18 million prescriptions.[10][11] In July 2021, the USFood and Drug Administration (FDA) approved an interchangeablebiosimilar insulin product called Semglee (insulin glargine-yfgn) for the treatment of diabetes.[12]
 | Parts of this article (those related to documentation) need to beupdated. Please help update this article to reflect recent events or newly available information.(January 2022) |
The long-acting insulin class, which includes insulin glargine, do not appear much better thanneutral protamine Hagedorn (NPH) insulin,[13] but do have a greater cost, making them, as of 2010, not cost effective for the treatment of type 2 diabetes.[14] In a previous review it was unclear if there is a difference inhypoglycemia, as there was not enough data to determine any differences with respect to long term outcomes,[15] however a more recentCochranesystematic review did not find clinically significant difference when comparing insulin glargine to NPH insulin,insulin detemir orinsulin degludec in the management of type 1 diabetes in either adults or children over periods of 6 months or longer.[13] 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 type 1 diabetes and in adults with type 2 diabetes.[12] Semglee is both biosimilar to, and interchangeable with its reference product Lantus (insulin glargine), a long-acting insulin analog.[12]
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.[16] However, a 2004 study found that mixing glargine with other insulins did not affect short-term glycemic profile.[17]
Common side effects includelow blood sugar, problems at the site of injection, itchiness, and weight gain.[7] Serious side effects includelow blood potassium.[7]
As of 2012, tentative evidence shows no association between insulin glargine andcancer.[18] Previous studies had raised concerns.[19]
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.[13]
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 preventsdeamidation 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.[20]
In June 2000, the European Commission formally approved the launching of Lantus by Sanofi-Aventis Germany in the European Union.[21] The admission was prolonged on 9 June 2005.[22]
A three-fold more concentrated formulation, brand name Toujeo, was introduced after FDA approval in 2015.[23][24]
As of 2025, there are two commercially available insulin glargine biosimilars in the USA:
Europe was much earlier with approving Insulin glargine biosimilars:
Patent protection for insulin glargine expired in Europe and the US in 2014.[29] Insulin glargine from competitorEli 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).[29]
Insulin glargine is available under brand names including Basaglar, Lantus, and Toujeo.
This article incorporates text from this source, which is in thepublic domain.