drugset / Trial / NCT02332824

A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria

NCT02332824 ↗

Phase 2 Completed 415 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to test the efficacy and safety on daily oral doses of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine the clinical dose of TAK-272.

Timeline

Start
2014-10-16
Primary completion
2016-08-18
Completion
2016-08-18

Outcome

Met primary endpoint

registry Placebo vs TAK-272 5 mg; p <0.0001; LS Mean difference -0.325 (95% CI -0.4845 to -0.1649); ANCOVA NCT02332824 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Candesartan cilexetil Unknown 8 mg Oral
Subject imarikiren Small molecule 5 mg Oral
Subject imarikiren Small molecule 20 mg Oral
Subject imarikiren Small molecule 40 mg Oral
Subject imarikiren Small molecule 80 mg Oral