A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
- Conditions
- Diabetes Mellitus and Hypercholesterolemia
- Interventions
- Drug: Rosuvastatin+Ezetimibe
- Registration Number
- NCT03217409
- Lead Sponsor
- Yuhan Corporation
- Brief Summary
A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.
- Detailed Description
This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- Subjects ≥ 19 or ≤ 75 years of age
- Subjects undergoing treatment for type 2 diabetes
- Subjects undergoing treatment of statin for hypercholesterolemia
- Fasting LDL-C ≤ 250mg/dL at the screening visit
- Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
- Fasting TG<500mg/dL
- Subjects with hypersensitivity reaction to Statin and Ezetimibe
- Subjects with severe kidney disease
- Subjects with HIV positive result at the screening
- Pregnant or breast-feeding subjects
- Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
- Insulin-treated Subjects
- Other exclusions applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rosuvastatin Rosuvastatin Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week Rosuvastatin+Ezetimibe Rosuvastatin+Ezetimibe Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week
- Primary Outcome Measures
Name Time Method Low density lipoprotein cholesterol (LDL-C) (%) baseline, Week 8 The rate of change(%) of LDL-C at Week 8 compared to the baseline
- Secondary Outcome Measures
Name Time Method Low density lipoprotein cholesterol (LDL-C) (100mg/dL) baseline, Week 8 The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline
Thiobarbituric acid reactive substances(TBARs) baseline, Week 8 Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline.
HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) baseline, Week 8 Variation of HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) at Week 8 compared to the baseline resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) change form the baseline at Week 8
LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) baseline, Week 8 Variation of LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) at Week 8 compared to the baseline Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) change form the base line at Week 8
Fibroblast Growth Factor 21 baseline, Week 8 Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline.
Trial Locations
- Locations (4)
Soon Chun Hyang University Hospital Bucheon
🇰🇷Gyeonggi-do, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Gumi
🇰🇷Gumi, Korea, Republic of