drugset / Trial / NCT02332824
A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |