The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.
This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
146
Reserch site
Chugoku, Japan
Reserch site
Chūbu, Japan
Reserch site
Hokkaido, Japan
Reserch site
Kanto, Japan
Reserch site
Kinki, Japan
Change in HbA1c From Baseline
Time frame: baseline and Week 16
Change in Fasting Plasma Glucose
Time frame: baseline and Week 16
Percent Change in Body Weight
Time frame: baseline and Week 16
Change in Blood Pressure
Time frame: baseline and Week 16
Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"
Time frame: Week 16
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Reserch site
Kyushu, Japan
Reserch site
Tōhoku, Japan