Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets. Twice a day, 1 tablet at a time for 12 weeks
50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
Chonbuk National University Hospital
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Gachon Medical School Gil Medical Center
Seoul, South Korea
Change in HbA1c before and after treatment
Time frame: 12 weeks
HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)
Time frame: 12 weeks
Fasting blood glucose level change and rate of change
Time frame: 12 weeks
Serum insulin, serum C-peptide level change
Time frame: 12 weeks
HOMA-R and HOMA-β change rate
Time frame: 12 weeks
Triglyceride, LDL-cholesterol and HDL-cholesterol change
Time frame: 12 weeks
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