Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled, randomized clinical trial

摘要

BackgroundTo examine efficacy of Subetta as an add-on to insulin therapy in patients with type 1 diabetes mellitus (T1DM) 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 was previously proved to activate insulin signaling pathway. MethodsA total of 144 randomized patients with poor glycemic control in basal-bolus insulin regime were included in intention-to-treat analysis in Subetta add-on therapy or placebo (n?=?72 in both groups). Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), basal and prandial insulin doses, number of hypoglycemia episodes confirmed by self-monitoring of blood glucose were recorded for 36?weeks. ResultsThe baseline characteristics of subjects did not differ between the two groups. HbA1c mean (±standard deviation) change was ?0.59?±?0.99% (95% CI ?0.84 to ?0.37) after 36?weeks in Subetta (vs. ?0.20?±?1.14%; 95% CI ?0.44 to 0.11 in placebo; p?=?0.028).The rate of overall hypoglycemia events was 7.9 per patient year (95% CI 7.1–8.6) in Subetta group and 7.6 (95% CI 6.9–8.4) in Placebo group (p?=?0.63). The basal and total insulin doses did not change at the end of 36?weeks in both groups. ConclusionsSubetta add-on therapy boosting insulin activity and improving glycemic control in patients with T1DM is proved to be beneficial. Clinical trial registrationClinicalTrials.govidentifier: NCT01868594.