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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,299
TA-7284-Low
TA-7284-High
Research site
Chugoku, Japan
Research site
Hokkaido, Japan
Research site
Kanto, Japan
Research site
Kinki, Japan
Research site
Kyushu, Japan
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
Time frame: 54 weeks
Change in HbA1c
Time frame: Week 52
Change in Fasting Plasma Glucose
Time frame: Week 52
Change in Body Weight
Time frame: Week 52
Change in Blood Pressure
Time frame: Week 52
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Research site
Shikoku, Japan
Research site
Tōhoku, Japan