Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284 JNJ-28431754 Canagliflozin Sodium Glucose Co-Transporter (SGLT2 inhibitor)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1299
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

Detailed description:
This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: TA-7284-Low intervention 2: TA-7284-High
Intervention descriptions: intervention 1: TA-7284-Low intervention 2: TA-7284-High

Protocol document: