Efficacy and safety of the russian GLP-1 receptor agonist semaglutide in patients with type 2 diabetes mellitus in real-world clinical practice (“QUEENPROMIS” study)

Objective: Evaluation of the efficacy of semaglutide (Queensenta^®) in real-world clinical practice in patients with type 2 diabetes mellitus (DM2).

Materials and methods: Thirty DM2 patients aged 40 to 65 years were examined. The study parameters were recorded at baseline and over time after 3 and 6 months while starting semaglutide therapy at a dose of 1 mg subcutaneously once a week. The analysis assessed changes in carbohydrate metabolism parameters, anthropometric parameters, changes in the blood lipid profile, liver and kidney function parameters, and the development of hypoglycemic states.

Results: By the end of the follow-up period, improvements in all carbohydrate metabolism parameters were noted: glycated hemoglobin levels decreased from 7.49±0.41 to 6.09±0.59% (p<0.05), and fasting glucose decreased from 8.63±1.18 to 6.58±1.08 mmol/L (p<0.05). Changes in anthropometric parameters were also noted. After 24 weeks of treatment, the mean body weight loss in the study cohort was 8.6 kg (-8.5% from baseline; p<0.05), body mass index -3.1 kg/m² (-8.6%; p<0.05). There was also a decrease in waist circumference by 10.1 cm and hip circumference by 6.6 cm (both p<0.05), as well as a decrease in fat mass (-5.4 kg; p<0.05). The decrease in triglyceride levels was -0.18±0.75 mmol/L, equivalent to -8.6%, but the changes did not reach statistical significance (p=0.22). Systolic blood pressure (SBP) decreased from 138.4±12.8 to 127.2±18.4 mmHg. The absolute decrease by week 24 was -11.8±16.0 mmHg (p<0.05). A decrease in diastolic blood pressure (DBP) by week 24 was noted by -5.6±9.6 mmHg (p<0.05). There was a tendency towards a decrease in the level of liver enzymes (ALT from 34.8±21.48 to 26.1±12.57 U/L, AST from 28.1±14.12 to 20.8±6.73 U/L over 24 weeks). An improvement in the quality of life was noted, which was assessed using the standardized EQ-5D-3L questionnaire, including the main domains of physical and psychoemotional state, as well as a visual analog scale (VAS), reflecting the patient’s subjective general health assessment. The total EQ-5D-3L score was 0.90±0.09 at baseline. After 24 weeks, the increase was +0.04 (p<0.05). The VAS score was 71.2±11.3 at baseline, and +7.0±10.2 at 24 weeks (p<0.05). Most patients reported improved well-being, decreased limitations in daily activities, and increased satisfaction with their current health. Side effects, such as transient dyspeptic symptoms, were reported in 36.7% of patients and did not require discontinuation of the drug. No hypoglycemic episodes were reported.

Conclusion: For the first time in Russia, a comprehensive study to evaluate the effect of intensified semaglutide (Quincenta^®) therapy on carbohydrate metabolism parameters, anthropometric parameters, blood lipid profiles, and liver and kidney function in patients who had not achieved treatment targets on metformin monotherapy was conducted. The safety of the studied therapy was also assessed. The results of the study confirm the high efficacy and safety of Quincenta^® in routine use in patients with type 2 diabetes mellitus.