High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes

Phase 4

• Conditions: Type 2 Diabetes; Atherosclerotic Cardiovascular Disease
• Interventions: Drug: Rosuvamibe; Drug: Monorova

• Registration Number: NCT03403556
• Lead Sponsor: Yuhan Corporation

Brief Summary

To assess the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe compared to high-intensity rosuvastatin in high atherosclerotic cardiovascular disease risk patients with type 2 diabetes

Detailed Description

This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 10mg/ezetimibe 10mg) vs. rosuvastatin 20mg treated for 24 weeks in atherosclerotic cardiovascular disease risk (≥ 7.5%) patients with type 2 diabetes

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-18
• Study Start: 2018-03-27
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

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Exclusion Criteria

• Type 1 diabetes

• Chronic hepatitis B or chronic hepatitis C, severe hepatic dysfunction (AST, ALT, ALP or CPK ≥ 3 x ULN) in screening

• Heavy drinking > 210g per week in screening

• Estimated GFR < 30mL/min/1.73m2 using the CKD-EPI formula in screening

• Undergoing renal replacement therapy (hemodialysis or peritoneal dialysis) in screening

• Having used other statin (HMG-CoA converting enzyme inhibitors) than Rosuvastatin or fibrate drugs in the last 3 months before screening

• Taking any medication (ex. Fenofibrate, Omega 3 fatty acid, etc.) that may affect LDL

  * Can be enrolled after 4 week-washout

• Having used thiazolidinedione drugs in the last 3 months before screening

• Taking cyclosporine concomitantly

• Positive HIV test in screening

• Pregnant, breastfeeding, or childbearing women who are not likely to use the appropriate contraceptive methods as judged by investigator

• Subjects with a medical history of myopathy and rhabdomyolysis due to use of statin

• Hypersensitive to statin and ezetimibe

• Having endocrine or metabolic disease known to affect serum lipids or lipoproteins

  • Uncontrolled diabetes (HbA1c ≥ 10%)
  • Uncontrolled thyroid dysfunction (TSH ≥ 3 x ULN)

• Subjects with a medical history of acute arterial diseases such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous coronary intervention in the last 6 months before screening

• Subjects with a surgical history of gastrointestine or drug absorption disorders due to gastrointestinal disorders

• Insulin-treated

• Taking other IPs in the last 30 days before screening

• Subjects who cannot discontinue contraindications that may affect the treatment of all types of diabetes and/or hypercholesterolemia during the study period

• Subjects with a significant or unstable medical or psychological condition that is judged by investigator to be detrimental to safety or to successful participation in the trial

• Other conditions than the above who is deemed to be ineligible to participate in the trial by investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvamibe ® Tab.	Rosuvamibe	Rosuvastatin 10mg/Ezetimibe10mg
Monorova ® Tab.	Monorova	Rosuvastatin 20mg

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C)	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline to week 24 in HOMA-B	Up to 24 weeks
Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk	Up to 12 weeks, Up to 24 weeks
Mean change from baseline to week 24 in sCD36	Up to 24 weeks
Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events	Up to 24 weeks
Mean change from baseline to week 24 in Fatty Liver Index (FLI)	Up to 24 weeks	FLI scores will be calculated based on triglycerides, BMI, r-GT and Waist circumference. BMI(kg/m\^2) will be calculated based on height(m) and weight(kg).
Proportion of subjects achieving the comprehensive lipid target (LDL-C < 70mg/dL, Non-HDL-C < 100mg/dL, and Apolipoprotein B < 80mg/dL) without withdrawn due to adverse events	Up to 24 weeks
Mean change from baseline to week 24 in calculated LDL cholesterol(mg/dL), HDL cholesterol(mg/dL), Triglyceride(mg/dL), non-HDL cholesterol(mg/dL), Apolipoprotein B(mg/dL), Apolipoprotein A1(mg/dL)	Up to 24 weeks
Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI)	Up to 24 weeks	hepatic steatosis index (HSI)= 8x(ALT/AST ratio)+BMI (+2, if female; +2, if diabetes mellitus)
Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS)	Up to 24 weeks
Mean change from baseline to week 24 in HbA1c	Up to 24 weeks
Mean change from baseline to week 24 in fasting plasma glucose (FPG)	Up to 24 weeks
Mean change from baseline to week 24 in HOMA-IR	Up to 24 weeks

Trial Locations

Locations (6)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

The Catholic University of Korea, St. Vincent's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of