Aim: To identify correlations between quality of life (QoL), emotional and mental state in patients with Type 2 diabetes mellitus (T2DM) and to evaluate its contribution in prediction of compliance. Materials & methods: The T2DM patients aged 18–75 years with at least 12 weeks of stable hypoglycemic therapy were included to this cross-sectional study. We used Mini Mental State Examination (MMSE) for mental state assessment, Hospital Anxiety and Depression Scale (HADS) for anxiety and depression level and EQ-5D for QoL. Compliance level was self-reported by patients. Results: The QoL positively correlates with MMSE score (p < 0.0001) and negatively with HADS anxiety (p < 0.0001) and depression (p < 0.0001) levels. The MMSE score is higher (p < 0.0001), and both HADS levels are lower (p < 0.01) in patients with higher compliance level. Conclusion: Cognitive function and psychoemotional state in T2DM patients are important for treatment compliance and QoL and are to be corrected whenever possible.

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

Background: The effects of liraglutide on body weight and hemoglobin A1C (HbA1c) level vary greatly. The cost of this drug negatively affects treatment adherence. Aim: To reveal the baseline patient characteristics, associated with a better response to liraglutide. Materials and methods: A total of 41 patients with BMI of 39.63 ± 7.59 kg/m2 who received liraglutide injection up to 1.8 or 3.0 mg/day for 6 months were enrolled. Demographic and anthropometric data, parameters of glycemic control, food intake, hormones and responses to the eating behavior questionnaire were collected. Results: Weight reduction was dose-dependent (p = 0.007). Liraglutide was not effective in patients with BMI >45 kg/m2. The baseline HbA1c level was a significant factor for HbA1c reduction. Lower leptin and higher glucagon-like-peptide 1 concentrations might predict better weight loss response to liraglutide. Conclusion: Drug-specific efficacy predictors were assumed; thus, further studies are needed to prove their significance.

Aim: To compare safety (immunogenicity) and efficacy of a biosimilar insulin GP-Lis25 and a reference insulin Ly-Lis25 (Humalog Mix 25) in Type 2 diabetes mellitus (T2D) patients. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 210 T2D patients, randomized 1:1 to twice-daily GP-Lis25 or Ly-Lis25. The primary end point was immune response at 26th week. Noninferiority margin for HbA1c was 0.4%. Results: Immune response frequency was similar in GP-Lis25 and Ly-Lis25 groups both at week 12 (p = 0.651) and 26 (p = 0.164). The difference of HbA1c change at week 26 was (95% CI) 0.01 (-0.27–0.28)%. Fasting plasma glucose, seven-point glucose profile and insulin dose were similar between groups. Safety did not differ between groups. Conclusion: GP-Lis25 and Ly-Lis25 demonstrated similar safety and efficacy. ClincalTrials.gov identifier: NCT04023344 .

Considering the received data and the existed knowledge on CYP2C9 influence on SUs pharmacokinetics and pharmacodynamics, we propose a possible approach to CYP2C9-guided SUs prescription for Russians.