A New Approach to Overcome Insulin Resistance in Patients with Impaired Glucose Tolerance: The Results of a Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety of Subetta

Abstract

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.

Comparative analysis of the drugs efficacy for carbohydrate metabolism early disorders (prediabetes) treatment: A review

“…Число НЯ в обеих группах значимо не различалось. Таким образом, применение препарата Субетта® снижало риск развития СД 2, продлевая период нормогликемии у пациентов с НТГ [44].…”

“…Таким образом, препарат Субетта® можно применять как для лечения РНУО и профилактики конверсии предиабета в СД, так и для коррекции проявлений СД 2 в составе комплексной терапии 3 [44,45].…”

“…Учитывая отсутствие в настоящее время прямых сравнительных исследований влияния метформина и препарата Субетта® на риск развития СД 2 у пациентов с РНУО, методом скорректированного непрямого сравнения результатов двойного слепого плацебо-контролируемого РКИ выполнен анализ эффективности и безопасности препарата Субетта® у пациентов с НТГ [44] с результатами ряда исследований метформина, аналогичных по критериям включения и эффективности.…”

Modeling of protein hydration dynamics is supported by THz spectroscopy of highly diluted solutions

“…These quantitative measurements have consistently assessed a nonlinear collection of concentrated surface material in the nanobubbles resulting from the series of dilutions associated with the flotation method, particularly when ethanol is present as part of the dilution mixture ( Chikramane et al, 2012 ). The interest in the HD samples as described in this manuscript is that they are prominently utilized in biomedical ( Geppe et al, 2021 ; Mkrtumyan et al, 2022 ) and technical applications ( Spitsin et al, 2020 ; Kamentsev and Bush, 2022 ). Namely, different drugs are used in clinics for treatment of various infectious ( Geppe et al, 2021 ) and non-infectious diseases ( Ivashkin et al, 2019 ; Mkrtumyan et al, 2022 ).…”

“…The interest in the HD samples as described in this manuscript is that they are prominently utilized in biomedical ( Geppe et al, 2021 ; Mkrtumyan et al, 2022 ) and technical applications ( Spitsin et al, 2020 ; Kamentsev and Bush, 2022 ). Namely, different drugs are used in clinics for treatment of various infectious ( Geppe et al, 2021 ) and non-infectious diseases ( Ivashkin et al, 2019 ; Mkrtumyan et al, 2022 ). As for the technical use of HD, both HD YBa 2 Cu 3 O y and HD Bi 3 TiNbO 9 added to ceramics of same content led to significant improvement of its properties which enables their use in materials for high-temperature applications ( Spitsin et al, 2020 ; Kamentsev and Bush, 2022 ).…”