The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
187
1000\~1500mg/day, 24weeks
0.6/1500mg\~0.9/1500mg/day, 24weeks
Bucheon St. Mary's Hospital
Bucheon-si, South Korea
Seoul National University Bundang Hospital
Bundang, South Korea
Change from baseline in HbA1c at week 24
Time frame: Baseline, week 24
Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24
Time frame: Baseline, week 4, 8, 12, 18, 24
Change from baseline in 2hr PPG and postprandial insulin at week 24
Time frame: Baseline, week 24
Change from baseline in FPG and HbA1c according to HbA1c at baseline(7~8%,8~9%, 9~10%, 10~11%)
Time frame: Baseline, week 4, 8, 12, 18, 24
Percentage of patients achieving HbA1c <7% at week 24
Time frame: week 24
Percentage of patients achieving HbA1c <6.5% at week 24
Time frame: week 24
Percentage of patients reaching FPG <126mg/dL at week 24
Time frame: week 24
Percentage of patients reaching 2hr PPG <200mg/dL at week 24
Time frame: week 24
Percentage of patients adjusting to the high dose
Time frame: week 24
Percentage of withdrawing patients due to uncontrolled glucose
Time frame: week 24
Change from baseline in serum lipid(T. cholesterol, HDL, LDL, TG) at week 24
Time frame: week 24
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Kyungpook University Hospital
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
National Health Insurance Coporation Ilsan Hospital
Ilsan, South Korea
Inha University Hospital
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Inje University Pusan Baik Hospital
Pusan, South Korea
Pusan National University Hospital
Pusan, South Korea
Asan Medical Center
Seoul, South Korea
...and 11 more locations
Glycemic variability
Glycemic variability is measured by M-value. M-value = ∑{\|10\*log(blood glucose/100)\|3}/n+{Max(blood glucose)-Min(blood glucose)}/20, M\<19: good, 19≤M\<32: fair, 32≤M: poor
Time frame: Baseline, week 8, 18, 24