The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.
This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
272
The patients will receive TA-7284-Low orally for 24 weeks.
The patients will receive TA-7284-High orally for 24 weeks.
The patients will receive Placebo orally for 24 weeks.
Reserch site
Chūbu, Japan
Reserch site
Kanto, Japan
Reserch site
Kinki, Japan
Reserch site
Shikoku, Japan
Reserch site
Tōhoku, Japan
Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
Time frame: baseline and 24 weeks
Change in Fasting Plasma Glucose
Time frame: Week 24
Change in Body Weight
Time frame: Week 24
Change in Blood Pressure
Time frame: Week 24
Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test
Time frame: Week 24
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs
Time frame: Week 24
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