Lantus Case Study

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Lantus was approved by the Federal Drug Administration (FDA) on April 20, 2000 for sale by Aventis Pharmaceuticals Incorporated, known today as Sanofi Aventis Pharmaceuticals Incorporated through a 2004 merger. Lantus is an insulin derivative designed to achieve very specific pharmacological properties to serve as an important component in the treatment of diabetes. Lantus is the brand name for insulin glargine which was constructed using recombinant DNA technology. The empirical formula of Lantus is C267H404N72O78S6. In addition to insulin glargine, Lantus also contains zinc, m-cresol, glycerol, polysorbate, and water.1 Insulin glargine is an insulin analog which delivers a basal level, or relatively steady base load, of the blood glucose…show more content…
When glargine is injected into the subcutaneous tissue, which has a normal pH of 7.4, it is neutralized. This causes the formation of micro precipitates. Hexamers are formed which have greater density and stability than human insulin and each begins to subdivide into three dimers. Each dimer then divide into two monomers. The monomers are physiologically the only active unit of insulin. This process is slow as the dissolution of free hexamers continues and drives a concentration which is relatively constant over…show more content…
Due to the DNA modifications required to design Glargine, the drug also has a strong affinity to the Insulin-like Growth Factor 1 receptor (IGF-1R). Data shows that insulin glargine’s strength of attraction to the IGF-1R is 641%, or more than 6 times the affinity of human insulin.8 The function of IGF-1R is to mediate the hormone IGF-1 which is involved in structural growth and mitogenic processes in the body. The concern is that increased affinity could lead to over activation of the IGF-1 receptor causing increased metabolic and mitogenic activities resulting in accelerated growth of any existing neoplasms.8 Some links to cancer have been suggested based on retrospective observational studies including studies including studies conducted by the UK Clinical Practice Research Datalink database, and National Health Registries from Denmark, Finland, Norway, and Sweden.9 Criticisms of the methods used in all studies to date have been levied and today there is no definitive consensus according to the FDA, with more research needed. Lantus also has some immunogenicity, in that at levels no different than human insulin, the autoimmune systems in some individuals will see insulin glargine as a foreign organism and release, in levels sufficient to engage anti-insulin glargine antibodies, mostly IgG type, to combat the insulin glargine. IgG, as one of

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