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.

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