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Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
Multi-center, Randomized, Double-blind, Phase III clinical trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia |
|
| Group II | Active Comparator | Metformin + placebo, Dosing to Type II DM with Dyslipidemia |
|
| Group III | Active Comparator | Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin + Rosuvastatin | Drug | Group I: Metformin + Rosuvastatin, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C (% change) | 16 weeks from baseline | |
| change of HbA1c | 16 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buchoen St. mary's Hospital | Bucheon-si | South Korea | ||||
| SeJong Hostpital |
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| Metformin + placebo |
| Drug |
Group II: Metformin + placebo, |
|
| placebo + Rosuvastatin | Drug | Group III: placebo + Rosuvastatin |
|
| Bucheon-si |
| South Korea |
| SoonChunHyang University Bucheon Hospital | Bucheon-si | South Korea |
| InJe University Busan paik Hospital | Busan | South Korea |
| Inje University Haeundae paik hospital | Busan | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Youngnam University Hostpital | Daegu | South Korea |
| Daeheon Eulji Medical Center | Daejeon | South Korea |
| KonYang University Hostpital | Daejeon | South Korea |
| Chosun University Hospital | Gwangju | South Korea |
| BunDang Jesang Hospital(DMC) | Gyeonggi-do | South Korea |
| Hallym University Sacred Heart hospital | Gyeonggi-do | South Korea |
| HanYang University Guri Hospital | Gyeonggi-do | South Korea |
| Inje University Ilsan paik hospital | Gyeonggi-do | South Korea |
| Myoung Ji Hospital | Gyeonggi-do | South Korea |
| Gachon Gil Hospital | Incheon | South Korea |
| Inchoen St. mary's Hospital | Incheon | South Korea |
| Eulji Hospital Nowon | Seoul | South Korea |
| Hallym University Kangnam Sacred Heart hospital | Seoul | South Korea |
| KangBuk SamSung Hospital | Seoul | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | South Korea |
| KonKuk University Medical Center | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| KyungHee University Hospital at Gangdong | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital(Famlily medicine) | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance hospital | Seoul | South Korea |
| SoonChunHayng University Hospital Seoul | Seoul | South Korea |
| The catholic University of Korea YEOUIDO St mary's Hospital | Seoul | South Korea |
| Korea University Guro hospital | Soeul | South Korea |
| Ajou University hospital | Suwon | South Korea |
| Wonju Severance Christian hospital | Wŏnju | South Korea |
| 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 |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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