Impaired glucose tolerance (IGT) is a common carbohydrate metabolism disorder world-wide. To evaluate the efficacy and safety of 12-week
Subetta therapy in correcting 2-h plasma
glucose in patients with IGT, a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of
antibodies to
insulin receptor β-subunit and endothelial
NO synthase,
Subetta increases the sensitivity of
insulin receptors by activating the
insulin signaling pathway. Oral
glucose tolerance test (OGTT), fasting plasma
glucose (FPG), and
glycated hemoglobin (HbA1c) were examined at screening, after 4 and 12 weeks. In Per Protocol population, 2-h plasma
glucose in the
Subetta group decreased by 2.05 ± 2.11 mmol/L (versus 0.56 ± 2.55 mmol/L in the Placebo group) after 12 weeks. The difference between the two groups was 1.49 ± 2.33 mmol/L (p < 0.0001). After 12 weeks, 65.2% of patients had 2-h plasma
glucose <7.8 mmol/L. FPG remained almost unchanged. HbA1c tended to decrease. The number of adverse events did not differ in both groups.
Subetta treatment is beneficial for patients with IGT; it also prevents progression of carbohydrate metabolism disorders.