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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
415
TAK-272 tablets
TAK-272 placebo-matching tablets
Candesartan cilexetil tablets
Change From End of Pre-treatment Period (Week 0) in Log-transformed Urine Albumin/Creatinine Ratio (UACR) at the End of Treatment Period (Week 12)
The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR.
Time frame: Week 0 and Week 12
Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point
The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR. Reported data is geometric mean ratio of UACR at each assessment point relative to Baseline.
Time frame: Weeks 2, 4, 8, 12, follow-up (Week 14) and End of Treatment
Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12)
Remission rate is defined as percentage of participants who have UACR \<30 mg/gCr and whose UACR decreased by ≥30% from the value at the end of the pre-treatment period (Week 0).
Time frame: Week 12
Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12)
Progression rate is defined as percentage of participants who have UACR ≥300 mg/gCr and whose UACR increased by ≥30% from the value at the end of the pre-treatment period \[Week 0\]. Meanwhile, the definition of transition to overt nephropathy also includes the case that UACR decreased to \<300 mg/gCr after the transition to overt nephropathy.
Time frame: Week 12
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Candesartan cilexetil placebo-matching tablets
Unnamed facility
Nagoya, Aichi-ken, Japan
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Chiba, Chiba, Japan
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Kisarazu-shi, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Fukutsu-shi, Fukuoka, Japan
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Kitakyuushu-shi, Fukuoka, Japan
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Kouriyama-shi, Fukushima, Japan
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Anchu-shi, Gunma, Japan
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Ota-shi, Gunma, Japan
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Ishikari-shi, Hokkaido, Japan
...and 58 more locations