Type 2 Diabetes Mellitus and Microalbuminuria Clinical Trial
Official title:
A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison, Phase 2 Study to Evaluate the Dose-response Relationship of the Efficacy and Safety of Oral Administration of TAK-272 in Patients With Type 2 Diabetes Mellitus and Microalbuminuria
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.
The drug being tested in this study is called TAK-272. This study evaluated the dose-response
relationship of the efficacy and safety of TAK-272 in participants with type 2 diabetes
mellitus and microalbuminuria.
The study enrolled 415 patients. Participants were randomly assigned to one of the 6
treatment groups:
- TAK-272 5 mg
- TAK-272 20 mg
- TAK-272 40 mg
- TAK-272 80 mg
- Candesartan cilexetil 8 mg
- Placebo (dummy inactive pill) for TAK-272 or Candesartan cilexetil - this was a tablet
that looks like the study drug but had no active ingredient
All participants were administered tablets, orally at the same time each day for 12 weeks in
double-blind manner. Participants were administered TAK-272 placebo 4 tablets and Candesartan
cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and
follow-up period (Week 12-14).
This multi-center trial was conducted in Japan. The overall time to participate in this study
is 22 weeks including 2 weeks of follow-up assessment period after last dose of study drug.
Participants made multiple visits to the clinic during these periods.
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