Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 180 Type 1 diabetes mellitus patients (HbA1c 6.5–12.0%), randomized 1:1 to once daily GP-Gla (n = 90) or Sa-Gla (n = 90). The primary end point was immune response at 26th week. Results: The frequency of immune response was similar in GP-Gla and Sa-Gla (p = 1.000). Groups were similar in terms of other safety end points. Mean HbA1c change from baseline was -0.66% for GP-Gla and -0.77% for Sa-Gla, and did not differ between groups (p = 0.326). Insulin doses, fasting plasma glucose and seven-point glucose profiles were similar between groups. Conclusion: GP-Gla and Sa-Gla demonstrated similar safety and efficacy. ClinicalTrials.gov Identifier: NCT04022993

Aim: To compare safety and efficacy of GP40071 insulin aspart (GP-Asp) and NovoRapid® (NN-Asp). Materials & methods: This randomized open-label, active-controlled, 26-week non-inferiority Phase III clinical trial enrolled 264 Type 1 diabetes mellitus patients (HbA1c: 7.1–12.0%) randomized 1:1 to once daily GP-Asp (n = 132) or NN-Asp (n = 132). The primary safety end point was immune response at week 26. Results: The groups were similar in frequency of immune response (p = 0.323) and in other safety end points. Mean HbA1c change from baseline was -0.57% for GP-Asp and -0.56% for NN-Asp and did not differ between groups (p = 0.955). Intergroup mean difference of HbA1c level change (95% CI) at week 26 from baseline was 0.00 (-0.26, 0.25) %. Insulin doses, fasting plasma glucose levels and seven-point glucose profiles were similar between groups (p > 0.05). The number of patients experiencing hypoglycemic episodes did not differ between the groups (p = 0.497). Conclusion: GP-Asp demonstrated similar safety and efficacy. Trial registration number: NCT04079413 ( ClinicalTrials.gov ).

In recent years, the pharmacy service of the Republic of Tatarstan has undergone significant structural and qualitative changes, which are caused by the beginning processes of denationalization and privatization. As a result, many pharmacies acquired the status of a legal entity, including pharmacy No. 350 in Kazan.

Five principal cliniconeurologic syndromes: cerebralofocal, hypothalamotruncal, hypertensiona- lohydrocephalic, asthenoneurotic, epileptic are distinguished. The manifestation of syndromes depended on the nature, localization and remoteness of the trauma. The disorder of the main nervous processes such as force, lability, mobility, concentration is revealed in these patients. The data obtained permit finding a true methodical approach to the treatment of patients with traumatic injury of brain.

The congress was opened by A. N. Demenkov, Head of the Department of Specialized Medical Care of the USSR Ministry of Health. In his report he pointed out radical changes in the structure of the service: reorganization of anti-obesity dispensaries into endocrinology centers; by 1991 they would open in all capitals of Union republics, regional and territorial centers and become organizational and methodological centers. In addition, in 1990 it is planned to establish endocrinology departments, including children's and surgical ones, in all large multidisciplinary hospitals.