Subetta, lozenges 100 pcs.

1 tablet contains:

Active ingredients:

affinity purified antibodies to endothelial NO synthase – 10,000 EMD*,

affinity purified antibodies to the C-terminal fragment of the beta subunit of the insulin receptor – 10,000 IMD*.

Excipients: isomalt, crospovidone, magnesium stearate.

* EMD – units of modifying action.

Pharmacotherapeutic group : hypoglycemic and other drugs in combinations.

Code ATH

A10VH.

Pharmacological properties

Pharmacodynamics

Subetta ^® is a complex drug that increases tissue sensitivity to insulin and normalizes the function of the vascular endothelium.

The molecular mechanisms of action of the drug are based on the effect on phosphorylation of the intracellular domains of the β-subunits of the insulin receptor, which leads to increased sensitivity of somatic cells to insulin and increased insulin-dependent glucose metabolism. The drug has also been shown to increase the production of adiponectin, a hormone that regulates energy homeostasis.

It was experimentally established that in a model of mixed type 1 and type 2 diabetes mellitus, the drug Subetta ^® reduced the level of glucose in the blood plasma and urine and restored impaired glucose tolerance in the oral sugar load test. The drug also reduced the content of ketone bodies in the urine, improved the general condition of the animals and increased their survival; had a positive effect on the dynamics of body weight, restoring the indicator to the physiological norm.

It was also experimentally demonstrated that in type 2 diabetes mellitus, the drug Subetta ^® reduced the level of glucose in the blood plasma. In addition, the drug contributed to the restoration of impaired glucose tolerance in the oral sugar load test, and also reduced animal feed intake.

Due to its effect on endothelial NO synthase, the drug has an endothelial protective effect, reduces vascular reactivity and vascular spasm, which helps prevent diabetes complications associated with impaired peripheral circulation and microcirculation.

Long-term administration of the drug Subetta ^® to laboratory animals did not lead to the development of significant side effects, including impaired hemostasis and hematopoiesis.

The experimentally established antihyperglycemic effect was confirmed in a clinical study in individuals with impaired glucose tolerance and increased body weight. When using the drug Subetta ^® for 12 weeks, the average value of 2-hour plasma glucose decreased to normal values. In 25% of patients with impaired glucose tolerance, HbA1c levels normalized to values
​​below 5.5%.

The antihyperglycemic effect of the drug was also observed in clinical studies in patients with type 1 and type 2 diabetes mellitus in the presence of insulin resistance. In type 1 diabetes mellitus, the decrease in the level of glycated hemoglobin (HbA1c) against the background of intensified (basal-bolus) insulin therapy by the 36th week of treatment averaged 0.59%; the use of the drug Subetta ^® for type 2 diabetes mellitus as part of complex therapy led to a statistically significant decrease in HbA1c after 12 weeks of therapy by an average of 0.53%.

Clinical studies conducted in patients with type 1 and type 2 diabetes mellitus demonstrated a favorable safety profile of the drug, which was confirmed by the absence of an effect of long-term
36-week administration on vital functions, biochemical and general clinical laboratory parameters, weight and body mass index, the frequency of hypoglycemia (including asymptomatic , night, day), as well as the absence of severe hypoglycemia.

Pharmacokinetics

The sensitivity of modern physicochemical methods of analysis (gas-liquid chromatography, high-performance liquid chromatography, gas chromatography-mass spectrometry) does not allow assessing the content of active substances in biological fluids, organs and tissues, which makes it technically impossible to study the pharmacokinetics of the drug Subetta ^® .

• Type 1 diabetes mellitus as an adjunct to basal-bolus insulin therapy.
• Diabetes mellitus type 2 as part of complex therapy.
• Impaired glucose tolerance, incl. in patients with increased body weight and obesity.

The score is not intended to divide the tablet into parts. The tablet should be kept in the mouth without swallowing until completely dissolved.

Diabetes mellitus type 1 and 2

For one dose – 1 tablet (keep in mouth until completely dissolved, not during meals).

The duration and frequency of administration is determined by the doctor and can vary from 2 to 4 times a day – depending on the degree of compensation of diabetes mellitus.

Impaired glucose tolerance

For one dose, 2 tablets 2 times a day (keep in the mouth until completely dissolved 15 minutes before meals).

The duration of treatment is determined by the doctor and, as a rule, is at least 12 weeks.