![]() Toujeo branded insulin glargine | |
Clinical data | |
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Trade names | Lantus, others |
Biosimilars | insulin glargine-aglr, insulin glargine-yfgn, Abasaglar, Rezvoglar, Semglee |
AHFS/Drugs.com | Monograph |
MedlinePlus | a600027 |
License data | |
Pregnancy category |
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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 | |
ChemSpider |
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UNII | |
KEGG | |
CompTox Dashboard (EPA) | |
ECHA InfoCard | 100.241.126 |
Chemical and physical data | |
Formula | C267H404N72O78S6 |
Molar mass | 6062.96 g·mol−1 |
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Insulin glargine sold under the brand name Lantus among others is a long-acting modified form of medical insulin, used in the management of type 1 and type 2 diabetes. [7] It is injected just under the skin. [7] Effects generally begin an hour after use. [7]
Common side effects include low blood sugar, problems at the site of injection, itchiness, and weight gain. [7] Other serious side effects include low blood potassium. [7] NPH insulin rather than insulin glargine is generally preferred in pregnancy. [8] After injection, microcrystals slowly release insulin for about 24 hours. [7] This insulin causes body tissues to absorb glucose 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 the World 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 US Food and Drug Administration (FDA) approved an interchangeable biosimilar insulin product called Semglee (insulin glargine-yfgn) for the treatment of diabetes. [12]
![]() | Parts of this article (those related to documentation) need to be updated.(January 2022) |
The long-acting insulin class, which includes insulin glargine, do not appear much better than neutral 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 in hypoglycemia, as there was not enough data to determine any differences with respect to long term outcomes, [15] 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 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 include low blood sugar, problems at the site of injection, itchiness, and weight gain. [7] Serious side effects include low blood potassium. [7]
As of 2012, tentative evidence shows no association between insulin glargine and cancer. [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 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. [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]
Abasaglar was approved for medical use in the European Union in September 2014. [25] [26]
Lusduna was approved for medical use in the European Union in January 2017. [27]
In March 2018, insulin glargine (Semglee) was approved for medical use in the European Union. [28]
In July 2021, insulin glargine-yfgn (Semglee) was approved for medical use in the United States as the first interchangeable biosimilar of Lantus. [12] The FDA granted approval of Semglee to Mylan Pharmaceuticals. [12]
Patent protection for insulin glargine expired in Europe and the US in 2014. [29] 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). [29]
Insulin glargine is available under brand names including Basaglar, Lantus, and Toujeo.