All-Russian observational non-interventional program on the study of the efficacy of Subetta in real-world clinical practice in patients with prediabetes (SILA)

Introduction . Treatment of type 2 diabetes mellitus (T2DM) and its complications impose a substantial economic burden on the healthcare system. Timely and high-quality follow-up monitoring of patients with prediabetes by primary care physicians helps prevent the development of diabetes mellitus and the progression of complications. Aim . To evaluate the experience of the use of Subetta in real-world clinical practice in patients with prediabetes. https://doi.org/10.21518/ms2025-128 Materials and methods . A 3-month Subetta monotherapy was assessed in 1,101 patients with verified prediabetes who had not previously received antidiabetic treatment. The follow-up monitoring period was 12 weeks, during which the patients received Subetta at a dose of 2 tablets twice a day. The primary efficacy endpoints included changes in fasting plasma glucose levels, glycated hemoglobin (HbA1c) levels and OGTT two-hour blood glucose levels as compared with baseline values 3 months after Subetta therapy. Results . The 12-week Subetta therapy showed a significant decrease in all studied carbohydrate metabolism parameters. The average decrease in HbA1c levels among all patients with prediabetes was 0.3% (p < 0.001). Over the follow-up period, OGTT two-hour blood glucose levels decreased by an average of 0.87 mmol/l (p < 0.001). The average fasting glucose level decrease was 0.62 mmol/l (p < 0.001). This therapy had a high safety profile, as only 8 adverse events were recorded in 5 patients (0.5% of cases) during the study. Conclusions . The study demonstrated high efficacy and a favourable safety profile of Subetta in monotherapy of patients with prediabetes. After 3 months of treatment, normoglycemia state based on the OGTT two-hour blood glucose levels was achieved in approximately 70% of patients.