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A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2203
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JW0201+C2202+C2203 | Experimental | Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) |
|
| C2202+C2203 | Placebo Comparator | Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Period(JW0201) | Drug | JW0201: 200mg/day For 24 weeks(PO, BID) C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (24 Weeks) lowering effect | change in HbA1c | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c lowering effect | change in HbA1c | 6, 12, 18, 32, 40, 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheol-Young Park | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Treatment Period(Placebo) | Drug | C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2203: 25 mg/day for 24 Weeks(PO, BID) |
|
|
| Extension Period(JW0201) | Drug | JW0201: 200mg/day For 28 weeks(PO, BID) C2022: ≥1,000 mg/day for 28 Weeks(PO, BID) C2203: 25 mg/day for 28 Weeks(PO, BID) |
|
|
| D004700 | Endocrine System Diseases |