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

Primary Purpose

Atherosclerotic Cardiovascular Disease, Type 2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvamibe
Monorova
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerotic Cardiovascular Disease focused on measuring High ASCVD risk patients with type 2 diabetes

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • ≥ 40 and < 75 years of age at the time of informed consent
  • Estimated 10-year ASCVD (atherosclerotic cardiovascular disease) risk ≥ 7.5% with type 2 diabetes according to the American Diabetes Association criteria in screening
  • HbA1c ≥ 6% and < 10% in screening
  • Body mass index (BMI) ≤ 35kg/m2 in screening
  • Female of childbearing with a negative pregnancy test who must agree to use contraception (including those not medically pregnant) during the study period
  • Written consent after being informed of the purpose and contents of the clinical trial and the characteristics and risks of IPs

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

Sites / Locations

  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Yeungnam University Medical CenterRecruiting
  • The Catholic University of Korea, St. Vincent's Hospital
  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rosuvamibe ® Tab.

Monorova ® Tab.

Arm Description

Rosuvastatin 10mg/Ezetimibe10mg

Rosuvastatin 20mg

Outcomes

Primary Outcome Measures

Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events
Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk
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
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)
Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI)
hepatic steatosis index (HSI)= 8x(ALT/AST ratio)+BMI (+2, if female; +2, if diabetes mellitus)
Mean change from baseline to week 24 in Fatty Liver Index (FLI)
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).
Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS)
Mean change from baseline to week 24 in HbA1c
Mean change from baseline to week 24 in fasting plasma glucose (FPG)
Mean change from baseline to week 24 in sCD36
Mean change from baseline to week 24 in HOMA-IR
Mean change from baseline to week 24 in HOMA-B

Full Information

First Posted
December 11, 2017
Last Updated
December 11, 2020
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03403556
Brief Title
High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes
Official Title
A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety Between High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in High ASCVD Risk Patients With Type 2 diabEtes (CREATE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease, Type 2 Diabetes
Keywords
High ASCVD risk patients with type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rosuvamibe ® Tab.
Arm Type
Experimental
Arm Description
Rosuvastatin 10mg/Ezetimibe10mg
Arm Title
Monorova ® Tab.
Arm Type
Active Comparator
Arm Description
Rosuvastatin 20mg
Intervention Type
Drug
Intervention Name(s)
Rosuvamibe
Intervention Description
Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Monorova
Intervention Description
Rosuvastatin 20mg qd for 24 weeks
Primary Outcome Measure Information:
Title
Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C)
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk
Time Frame
Up to 12 weeks, Up to 24 weeks
Title
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
Time Frame
Up to 24 weeks
Title
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)
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI)
Description
hepatic steatosis index (HSI)= 8x(ALT/AST ratio)+BMI (+2, if female; +2, if diabetes mellitus)
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 24 in Fatty Liver Index (FLI)
Description
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).
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS)
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 24 in HbA1c
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 24 in fasting plasma glucose (FPG)
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 24 in sCD36
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 24 in HOMA-IR
Time Frame
Up to 24 weeks
Title
Mean change from baseline to week 24 in HOMA-B
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
≥ 40 and < 75 years of age at the time of informed consent Estimated 10-year ASCVD (atherosclerotic cardiovascular disease) risk ≥ 7.5% with type 2 diabetes according to the American Diabetes Association criteria in screening HbA1c ≥ 6% and < 10% in screening Body mass index (BMI) ≤ 35kg/m2 in screening Female of childbearing with a negative pregnancy test who must agree to use contraception (including those not medically pregnant) during the study period Written consent after being informed of the purpose and contents of the clinical trial and the characteristics and risks of IPs 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
Facility Information:
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyuchang Won
Phone
53-620-3846
Ext
82
Email
kcwon@med.yu.ac.kr
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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