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The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.
The aim of this phase 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-501 0.5mg | Experimental | CKD-501 0.5mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-501 0.5mg | Drug | CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Glycosylated Hemoglobin | Baseline, 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in in Glycosylated Hemoglobin | Baseline, 52weekes | |
| Change from baseline in Fasting plasma glucose | Baseline, 24weeks, 52weeks | |
| HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun ho Yoon, Ph.D | Contact | 82-2-2258-6007 | yoonk@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kun ho Yoon, Ph.D | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| C546215 | lobeglitazone |
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| Placebo | Drug | Placebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study). |
|
| Baseline, 24weeks |
| Change from baseline in Total Cholesterol | Baseline, 24weeks, 52weeks |
| Evaluate safety of CKD-501 from number of participants with adverse events | Baseline, 24weeks, 52weeks |
| Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance) | Baseline, 24weeks, 52weeks |
| Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function) | Baseline, 24 weeks, 52 weeks |
| Change from baseline in QUICKI(Quantitative Insulin Check Index) | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Triglycerides | Baseline, 24 weeks, 52 weeks |
| Change from baseline in LDL-Cholesterol | Baseline, 24 weeks, 52 weeks |
| Change from baseline in HDL-Cholesterol | Baseline, 24 weeks, 52 weeks |
| Change from baseline in non-HDL-Cholesterol | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Small Dense LDL-Cholesterol | Baseline, 24 weeks, 52 weeks |
| Change from baseline in FFA(Free Fatty Acid) | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Apo-B | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Apo-CⅢ | Baseline, 24 weeks, 52 weeks |
| Change from baseline in Apo-AⅠ | Baseline, 24 weeks, 52 weeks |