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To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin | Placebo Comparator | only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo) |
|
| Rosuvastatin | Placebo Comparator | only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo) |
|
| FDC | Experimental | Gemigliptin & Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin and/or Rosuvastatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change | Baseline(Day 0) to Treatment (last visit, w24) | |
| LDL-C change rate | Baseline(Day 0) to Treatment (last visit, w24) |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | (Gemigliptin/Rosuvastatin FDC vs. Gemigliptin) | Baseline(Day 0) to Treatment (last visit, w24) |
| LDL-C change rate | (Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline(Day 0) to Treatment (last visit, w24) |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |