Expiration date: 01/2024

Pharmacokinetics

Suction. After p/to the introduction patients with diabetes mellitus type 2 dellagloria Cmax in plasma observed after 48 h. After multiple p/to the introduction dellagloria in the dose of 1.5 mg in patients with diabetes mellitus type 2 average Cmax and AUC were approximately 114 ng/ml and 14,000 ng·h/ml, respectively. Css in plasma was observed after 2-4 nedovedeniya dellagloria in the dose of 1.5 mg 1 once a week. Concentration after p/to the introduction of a single dose dellagloria (1.5 mg) in the abdomen, thigh or upper arm were comparable. Average absolute bioavailability after a single dellagloria p/Vvedenie in a dose of 1.5 or 0.75 mg were 47 and 65%, respectively.

Distribution. After p/to the introduction dellagloria at doses of 0.75 or 1.5 mg to patients with diabetes type 2 average Vss approximately a 19.2 and 17.4 l, respectively.

Metabolism. It is believed that blagutin cleaved into its component amino acids via the basic way of catabolism of proteins.

Excretion. The average clearance dellagloria in humans at steady state after administration at doses of 0.75 or 1.5 mg was and 0,073 0,107 l/h, respectively, with T1/2 of 4.5 and 4.7 days respectively.

Special groups of patients

Elderly patients (over 65 years). Patient age had no clinically significant impact on pharmacokinetic and pharmacodynamic properties dellagloria.

Gender and racial identity. Gender and race had no clinically meaningful effect on the pharmacokinetics dellagloria.

Body weight or BMI. Pharmacokinetic analysis revealed a statistically significant inverse relationship between body weight or BMI and therapy dellagloria, however, a clinically relevant influence of body weight or BMI on glycaemic control were noted.

Patients with impaired renal function. The pharmacokinetics dellagloria was assessed during a clinical pharmacological studies, in General, it was similar in healthy participants and patients with impaired renal function mild to severe (Cl creatinine<30 ml/min), including end-stage renal disease (with hemodialysis). In clinical studies, the safety profile of dellagloria in patients with impaired renal function, the average degree was similar to the safety profile in the General population of patients with diabetes mellitus type 2. These studies have not included patients with severe impairment of renal function or end-stage renal failure.

Patients with impaired liver function. The pharmacokinetics dellagloria was assessed during a clinical pharmacological studies in which patients with impaired liver function there was a statistically significant reduction of mean values of Cmax and AUC by 30 and 33%, respectively, compared with healthy patients. When deterioration of function has increased the time to reach Cmax dellagloria. The pharmacokinetic parameters dellagloria not depended on the degree of liver dysfunction. Such changes were not considered clinically significant.

Children. Pharmacokinetics studies dellagloria in children have not been conducted.

The testimony of the drug Trulicity™

The drug Trulicity™ is indicated in adult patients with diabetes type 2 to improve glycemic control:

  • as monotherapy, if diet and exercise do not provide adequate glycaemic control in patients who have not shown the use of Metformin because of intolerance or a contraindication;
  • in the form of a combination therapy in combination with other hypoglycemic drugs, including insulin, when these medicines together with diet and exercise do not provide adequate glycemic control.

Contraindications

  • hypersensitivity to the active or any of the excipients included in the product;
  • diabetes mellitus type 1;
  • diabetic ketoacidosis;
  • severe violations of kidney function;
  • congestive heart failure;
  • severe gastrointestinal disease, including severe paresis of the stomach;
  • acute pancreatitis;
  • pregnancy;
  • the period of breastfeeding;
  • children up to age 18 years.

Caution: patients taking oral drugs that require rapid absorption in the gastrointestinal tract; patients aged 75 years and older.

Trulicity
(Dulaglutide)