drugset / Trial / NCT01868646

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

NCT01868646 ↗

Phase 4 Completed 190 enrolled Materia Medica Holding
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

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

Timeline

Start
2013-05-07
Primary completion
2016-06-15
Completion
2016-06-15

Outcome

Met primary endpoint

registry analysis (superiority test); Subetta vs Placebo; p = 0.0002; Mixed Models Analysis NCT01868646 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Subetta Protein / enzyme biologic 1 unknown Oral