This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)
This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
The patients will receive Canagliflozin orally for 36 weeks
Reserch site
Chugoku, Japan
Reserch site
Chūbu, Japan
Reserch site
Hokkaido, Japan
Reserch site
Kanto, Japan
Reserch site
Kinki, Japan
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Time frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
Change in Percentage of HbA1c
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Change in Fasting Plasma Glucose
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Percentage Change in Body Weight
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
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Reserch site
Kyushu, Japan
Reserch site
Tōhoku, Japan