The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
255
orally administered once daily for 24 weeks
orally administered once daily for 24 weeks
orally administered once daily for 24 weeks
Unnamed facility
Chubu Region, Japan
Unnamed facility
Chugoku Region, Japan
Unnamed facility
Kansai Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kyushu Region, Japan
Changes in HbA1C from baseline
Time frame: Week 24 (LOCF)
Changes in fasting blood glucose (FBG) from baseline
Time frame: Week 24
Changes in 2 hour postprandial blood glucose (PPG) from baseline
Time frame: Week 24
Changes in 3 hour PPG AUC from baseline
Time frame: Week 24
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Unnamed facility
Shikoku Region, Japan
Unnamed facility
Tohoku Region, Japan