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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

Diabetes Research and Clinical Practice Jun 03, 2018

Mkrtumyan A, et al. - A multicenter, double-blind, placebo-controlled, randomized clinical trial was performed to investigate the efficacy of Subetta as an add-on to insulin therapy in patients with type 1 diabetes mellitus (T1DM). For the purpose of this investigation, the researchers involved an aggregate of 144 randomized patients with poor glycemic control in basal-bolus insulin regime in intention-to-treat analysis in Subetta add-on therapy or placebo (n = 72 in both groups). They recorded hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), basal and prandial insulin doses, number of hypoglycemia episodes confirmed by self-monitoring of blood glucose for 36 weeks. In patients with T1DM, Subetta add-on therapy boosting insulin activity and improving glycemic control was proved to be beneficial.
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