Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus

Summary

The purpose of this study is: * to assess clinical efficacy of Subetta in the combined treatment of type I diabetes mellitus; * to assess safety of Subetta in the combined treatment of type I diabetes mellitus.

Timeline

Start

2013-05-07

Primary completion

2016-07

Completion

2016-07-10

Outcome

Met primary endpoint

registry analysis (superiority test); Subetta vs Placebo; p = 0.019; Mixed Models Analysis NCT01868594 ↗

Publications

• Mkrtumyan A, Romantsova T, Vorobiev S, Volkova A, Vorokhobina N, Tarasov S, Putilovskiy M, Andrianova E, Epstein O. 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 Res Clin Pract. 2018 Aug;142:1-9. doi: 10.1016/j.diabres.2018.04.044. Epub 2018 May 26.

Drugs

Indications