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The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator |
| |
| CJ-30001/CJ-30002 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 1000~1500mg/day, 24weeks |
| |
| CJ-30001/CJ-30002 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at week 24 | Baseline, week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24 | Baseline, week 4, 8, 12, 18, 24 | |
| Change from baseline in 2hr PPG and postprandial insulin at week 24 | Baseline, week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon St. Mary's Hospital | Bucheon-si | South Korea | ||||
| Seoul National University Bundang Hospital |
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| Drug |
0.6/1500mg~0.9/1500mg/day, 24weeks |
|
| Change from baseline in FPG and HbA1c according to HbA1c at baseline(7~8%,8~9%, 9~10%, 10~11%) | Baseline, week 4, 8, 12, 18, 24 |
| Percentage of patients achieving HbA1c <7% at week 24 | week 24 |
| Percentage of patients achieving HbA1c <6.5% at week 24 | week 24 |
| Percentage of patients reaching FPG <126mg/dL at week 24 | week 24 |
| Percentage of patients reaching 2hr PPG <200mg/dL at week 24 | week 24 |
| Percentage of patients adjusting to the high dose | week 24 |
| Percentage of withdrawing patients due to uncontrolled glucose | week 24 |
| Change from baseline in serum lipid(T. cholesterol, HDL, LDL, TG) at week 24 | week 24 |
| 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 | Baseline, week 8, 18, 24 |
| Bundang |
| South Korea |
| 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 |
| Eulji Medical Center | Seoul | South Korea |
| Hallym University Medical Center(Gangdong) | Seoul | South Korea |
| Hallym University Medical Center(Gangnam) | Seoul | South Korea |
| Kangbuk Samsung Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyung Hee University Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul St. Mary's hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Uijeongbu St. Mary's Hospital | Uijeongbu-si | South Korea |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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