The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
224
Research Site
Osaka, Japan
Research Site
Suita, Japan
Research Site
Tokyo, Japan
Change in Haemoglobin A1c (HbA1c)
Time frame: from baseline to 4 months
Change in Fasting Plasma Glucose (FPG)
Time frame: from baseline to 4 months
Number of Responders in Terms of HbA1C ≤ 7%
Time frame: at 4th month
Number of Responders in Terms of HbA1C ≤ 6.5%
Time frame: at 4th month
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: from baseline to 4 months
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: from baseline to 4 months
Percentage Change in Triglycerides
Time frame: from baseline to 4 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: from baseline to 4 months
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