Clinical trial NCT02332824
Conditions: Type 2 Diabetes Mellitus and Microalbuminuria
Keywords: Pharmacological therapy
Sponsor: Takeda
Start date: 2014-10-16; Completion date: 2016-08-18
Enrollment: 415 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
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.

Arms: arm 1: TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet orally, once daily for up to 12 weeks.

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). arm 2: TAK-272 5 mg one tablet, TAK-272 placebo 3 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks.

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). arm 3: TAK-272 20 mg one tablet, TAK-272 placebo 3 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks.

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). arm 4: TAK-272 20 mg 2 tablets, TAK-272 placebo 2 tablets, and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks.

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). arm 5: TAK-272 20 mg 4 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks.

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). arm 6: TAK-272 placebo 4 tablets and Candesartan cilexetil 8 mg one tablet, orally, once daily for up to 12 weeks.

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).
Interventions: intervention 1: TAK-272 intervention 2: TAK-272 Placebo intervention 3: Candesartan cilexetil intervention 4: Candesartan cilexetil Placebo
Intervention descriptions: intervention 1: TAK-272 tablets intervention 2: TAK-272 placebo-matching tablets intervention 3: Candesartan cilexetil tablets intervention 4: Candesartan cilexetil placebo-matching tablets

Protocol documents: