Subetta, lozenges 100 pcs.

The drug Subetta® is indicated for use in adults.
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.

Indications

Subetta® is indicated for use in adults.
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.

Pharmacological effect

Pharmacotherapeutic group: hypoglycemic and other drugs in combinations.

ATX code

A10BX.

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 glucose levels in 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
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 diabetes mellitus types 1 and 2 demonstrated a favorable safety profile of the drug, which was confirmed by the absence of the effect of long-term
36-week intake for vital functions, biochemical and general clinical laboratory parameters, weight and body mass index, frequency of hypoglycemia (including asymptomatic, nocturnal, daytime), 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®.

Special instructions

Before using Subetta®, consult your doctor.

Impact on the ability to drive vehicles and machinery
The drug Subetta® does not affect the ability to drive vehicles and other potentially dangerous mechanisms.

Composition

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.

Pregnancy

Pregnancy
The use of Subetta® is contraindicated during pregnancy.

Breastfeeding period
The use of Subetta® is contraindicated during breastfeeding.

Contraindications

Increased individual sensitivity to the components of the drug.
Age up to 18 years.
Pregnancy, breastfeeding period.

Side Effects

Individual hypersensitivity reactions to the components of the drug are possible.

Interaction

There were no cases of interaction with other drugs of various classes.

Overdose

In case of overdose, dyspepsia may occur due to the excipients included in the drug.
Treatment is symptomatic.

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

Materia Medica Holding, Russia