Insulin aspart – human nandrolone phenylpropionate profile insulin analog short-acting, produced by recombinant DNA biotechnology using the strain Saccharomyces cerevisiae, wherein the amino acid proline in position B28 is replaced by aspartic acid. Interacts with the specific receptor cytoplasmic outer cell membrane to form insulin-receptor complex stimulates intracellular processes, in Vol. H. The synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, and others.).Reduction in blood glucose is due to an increase of intracellular transport, increased tissue uptake, stimulation of lipogenesis, glikogenogeneza, decreased glucose production by the liver and other speed.
Substitution of amino acid proline in position B28 with Aspartic acid insulin aspart molecules reduces the tendency to the formation of hexamers, which is observed in conventional insulin solution. Therefore aspart insulin is absorbed much faster from subcutaneous fat and begins to act faster than soluble human insulin. Insulin aspart strongly reduces the content of blood glucose in the first 4 hours after ingestion than soluble human insulin. The duration of action of insulin aspart after subcutaneous administration shorter than soluble human insulin.
After subcutaneous administration of the drug action begins within 10-20 minutes after administration. Maximum effect is observed 1-3 hours after injection. The duration of action of the drug is 3-5 hours.
Clinical trials in patients with type 1 diabetes have demonstrated reduced risk of nocturnal hypoglycaemia with insulin aspart use compared to soluble human insulin. The risk of daytime hypoglycaemia was not significantly increased.
Insulin aspart is equipotent to soluble human insulin on a molar basis of indicators.
Adults. Clinical trials in patients with type 1 diabetes mellitus exhibit lower postprandial blood glucose concentration when administered insulin aspart, as compared to soluble human insulin.
Elderly: A randomized double-blind crossover study of pharmacokinetics and pharmacodynamics (PK / PD) of insulin aspart and soluble human insulin in elderly patients with type 2 diabetes (19 patients aged 65-83 years, mean age 70 years). The relative differences pharmacodynamic properties between insulin aspart and human insulin in elderly patients were similar to those in healthy subjects and in younger patients with diabetes mellitus.
Children and adolescents. The use of insulin aspart in children showed similar results extended glycemic control compared with soluble human insulin.
Clinical study with soluble human insulin before food intake and insulin aspart postprandial was conducted in young children (26 patients aged 2 to b s); and the PK / PD study using single dose was conducted in children (6-12 years) and adolescent (13-17 years). The pharmacodynamic profile of insulin aspart children was similar to that in adult patients.
Pregnancy: Clinical studies of comparative safety and efficacy of insulin aspart and human insulin in the treatment of pregnant women with type 1 diabetes (322 surveyed pregnant women, of whom 157 received insulin aspart, 165 – human insulin) did not reveal any adverse effects of insulin aspart on pregnancy or . the fetus / newborn health
Additional clinical study of 27 women with gestational diabetes, treated with insulin aspart and human insulin (insulin aspart received 14 women, human insulin – 13) suggest comparable safety profiles, along with a significant improvement in glucose control after meals for the treatment of insulin aspart.
Liver failure: Study of pharmacokinetics after a single dose of insulin aspart was performed in 24 patients, liver function which is in the range from normal to severe disorders. In subjects with hepatic impairment absorption rate of insulin aspart function was reduced and more unstable, resulting in a slowdown was t max from about 50 min in subjects with normal hepatic function to about 85 min in subjects with hepatic impairment secondary to severe function. The area under the curve “concentration-time”, the maximum plasma concentration and the total clearance of the drug (AUC, C max and CL / F) were similar in subjects with impaired and normal liver function.
Insufficiency of kidney function. Study nandrolone phenylpropionate profile the pharmacokinetics of insulin aspart was performed in 18 patients, whose renal function ranged from normal to severe disturbances. There were no apparent effect on creatinine clearance value AUC, C max , t max insulin aspart. These parameters were limited to patients with impaired renal function, moderate and severe forms. Persons with renal failure requiring dialysis, were not included in the study.
Preclinical safety data: Preclinical testing did not reveal any danger to humans, based on conventional pharmacological safety of these studies, the toxicity of repeated application, genotoxicity and reproductive toxicity.
In in vitro tests, including binding to the insulin receptor and IGF-1, as well as effects on cell growth, insulin aspart behavior very similar to that of human insulin. The research results also show that the dissociation of binding to a receptor of insulin aspart insulin is equivalent to that of human insulin.
Do not use the drug in children under 2 years of age, because clinical trials in children younger than 2 years of age have not been conducted.
Application of pregnancy and during breastfeeding
Nandrolone phenylpropionate profile can be administered during pregnancy. Data from two randomized controlled clinical trials (157 + 14 pregnant women surveyed) did not reveal any adverse effect of insulin aspart on pregnancy or the health of the fetus / newborn when compared to human insulin (see. Section ”
“). It is recommended careful monitoring of blood glucose and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) throughout pregnancy and during a possible pregnancy. Insulin requirements usually decreases trimester I and II gradually increases during and III trimester of pregnancy. Shortly after birth, insulin requirements quickly returns to a level that was before pregnancy.
During the period of breastfeeding can be used, as insulin woman breast-feeding is not a threat to the child. However, it may be necessary to correct dose.
Dosage and administration:
Typically, the drug is used in combination with the average duration of insulin or long-acting preparations which are administered at least one time a day. In order to achieve optimal glycemic control is recommended to regularly measure the concentration of glucose in the blood and adjust the dose of insulin. steroiden kaufen
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