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1Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
2Department of Biostatistics, Korea University College of Medicine, Seoul, Korea
3Department of Endocrinology and Metabolism, Kyung Hee University Hospital, College of Medicine, Kyung Hee University, Seoul, Korea
4Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Korea
5Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea
6Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
7Division of Endocrinology, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea
8Division of Endocrinology and Metabolism, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea
9Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea
10Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Daejeon, Korea
11Division of Endocrinology and Metabolism, Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea
12Department of Internal Medicine, Pusan National University Hospital, Busan, Korea
13Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea
14Department of Internal Medicine, Bucheon Sejong Hospital, Bucheon, Korea
15Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
16Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
17Department of Internal Medicine, Research Institute of Metabolism and Inflammation, Yonsei University Wonju College of Medicine, Wonju, Korea
18Department of Internal Medicine, Gachon University College of Medicine, Incheon, Korea
19Division of Endocrinology and Metabolism, Department of Internal Medicine, Research Institute of Clinical Medicine of Jeonbuk National University Medical School-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Korea
20Division of Endocrinology, Department of Internal Medicine, Myongji Hospital, Goyang, Korea
21Division of Endocrinology and Metabolism, Department of Internal Medicine, Jeju National University College of Medicine, Jeju, Korea
22Division of Endocrinology and Metabolism, Chosun University College of Medicine, Gwangju, Korea
23Division of Endocrinology and Metabolism, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
24Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea
25Department of Internal Medicine, Inje University College of Medicine, Busan, Korea
26Department of Endocrinology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea
27Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea
28Department of Internal Medicine, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Korea
29Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
30Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
31Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea
32Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea
33Department of Endocrinology and Metabolism, Inha University College of Medicine, Incheon, Korea
34Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
35Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea
36Big Data Steering Department, National Health Insurance Service, Wonju, Korea
37Department of Internal Medicine, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea
38Division of Endocrinology and Metabolism, Department of Internal Medicine, Dong-A University Medical Center, Dong-A University College of Medicine, Busan, Korea
39Division of Endocrinology and Metabolism, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea
40Division of Endocrinology and Metabolism, College of Medicine, Hallym University, Chuncheon, Korea
41Department of Endocrinology and Metabolism, Konyang University Hospital, Konyang University College of Medicine, Daejeon, Korea
42Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea
43Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
44Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea
Copyright © 2024 Korean Endocrine Society
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICTS OF INTEREST
This study is supported by Hyundai Pharm.
AUTHOR CONTRIBUTIONS
Conception or design: K.C.W., Y.S.C., S.G.K. Revision of study protocol: N.H.K., J.L., S.C., J.M.Y., I.K.J., S.L., W.J.K., K.S., H.C.C., H.M.Y., K.A.K., S.S.K., S.H.L., C.H.K., S.H.K., Y.L., C.H.C., S.L., H.Y.J., J.H.L., G.K., S.Y.K., J.K., J.H.L., T.N.K., H.J.J., J.H.L., J.H.J., H.J.Y., H.K.K., H.K.P., I.S.N.G., S.H., C.W.A., J.H.Y., J.H.P., K.G.P., C.H.P., K.H.J., O.H.R., K.Y.P., E.G.H., B.S.C., K.C.W., Y.S.C., S.G.K. Drafting the work or revising: N.H.K., J.L., K.C.W., Y.S.C., S.G.K. Final approval of the manuscript: K.C.W., Y.S.C., S.G.K.
Inclusion criteria |
Patients diagnosed with type 2 diabetes according to American Diabetes Association criteria |
Age ≥19 years |
Non-HDL-C ≥100 mg/dL, TG ≥200, <500 mg/dL on moderate-intensity statins |
Presence of cardiovascular disease or at least one of cardiovascular risk factorsa |
Exclusion criteria |
Pregnant or breastfeeding women |
Uncontrolled hyperglycemia (HbA1c >12.0%) |
Serum creatinine >2.5 mg/dL or eGFR <30 mL/min/1.73 m2 |
Gall bladder disease, myopathy, or rhabdomyolysis requiring treatment |
Elevated liver enzymes (AST, ALT) >3 times the upper normal limit |
Hypersensitivity to study drugs |
HDL-C, high-density lipoprotein cholesterol; TG, triglyceride; HbA1c, glycosylated hemoglobin; eGFR, estimated glomerular filtration rate; AST, aspartate aminotransferase; ALT, alanine aminotransferase.
a Cardiovascular diseases include coronary artery disease, ischemic stroke, transient ischemic attack, carotid artery disease, and peripheral artery disease. Cardiovascular risk factor includes abdominal aortic aneurysm, duration of diabetes ≥10 years, age (men ≥45 years, women ≥55 years), family history of premature atherosclerotic cardiovascular disease, hypertension, smoking, low HDL-C level (<40 mg/dL), albuminuria, chronic kidney disease (eGFR <60 mL/min/1.73 m2), retinopathy, neuropathy, left ventricular hypertrophy.
Variable | Screening/baselinea (visit 1) | Randomization | Visit 2 (3 mo) | Visit 3 (12 mo) | Visit 4 (24 mo) | Visit 5 (36 mo) | Visit 6 (48 mo) |
---|---|---|---|---|---|---|---|
Visit windows, day | ±1 mo | ±3 mo | ±3 mo | ±3 mo | ±3 mo | ||
Written informed consent | X | ||||||
Demographicsb | X | ||||||
Physical examination | X | ||||||
Vital sign | X | X | X | X | X | X | |
Past medical history | X | X | X | X | X | X | |
12-lead ECG | X | X | X | X | X | X | |
Inclusion/exclusion criteria | X | ||||||
Randomization to treatment groups | X | ||||||
Laboratory testc | X | X | X | X | X | X | |
Assessment of trial outcomes/adverse events | X | X | X | X | X | X |
ECG, electrocardiogram.
a Screening procedure and baseline measurements are conducted on the same day;
b Demographic information includes age, date of birth, sex, height, weight, waist circumference, smoking history, alcohol consumption, and physical activity level;
c Laboratory tests including hematology (red blood cell count, white blood cell [WBC] count, hemoglobin, hematocrit, platelet, WBC differential count, high-sensitivity C-reactive protein), blood chemistry tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase, creatinine phosphokinase, total bilirubin, creatinine), urinalysis (pH, specific gravity, protein, WBC), urine albumin/creatinine, blood glucose test (glycosylated hemoglobin, fasting plasma glucose, fasting insulin), lipid profile (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], triglyceride, non-HDL-C) will be measured at the site visits or recorded from electronic medical records.
Inclusion criteria |
Patients diagnosed with type 2 diabetes according to American Diabetes Association criteria |
Age ≥19 years |
Non-HDL-C ≥100 mg/dL, TG ≥200, <500 mg/dL on moderate-intensity statins |
Presence of cardiovascular disease or at least one of cardiovascular risk factors |
Exclusion criteria |
Pregnant or breastfeeding women |
Uncontrolled hyperglycemia (HbA1c >12.0%) |
Serum creatinine >2.5 mg/dL or eGFR <30 mL/min/1.73 m2 |
Gall bladder disease, myopathy, or rhabdomyolysis requiring treatment |
Elevated liver enzymes (AST, ALT) >3 times the upper normal limit |
Hypersensitivity to study drugs |
Variable | Screening/baseline |
Randomization | Visit 2 (3 mo) | Visit 3 (12 mo) | Visit 4 (24 mo) | Visit 5 (36 mo) | Visit 6 (48 mo) |
---|---|---|---|---|---|---|---|
Visit windows, day | ±1 mo | ±3 mo | ±3 mo | ±3 mo | ±3 mo | ||
Written informed consent | X | ||||||
Demographics |
X | ||||||
Physical examination | X | ||||||
Vital sign | X | X | X | X | X | X | |
Past medical history | X | X | X | X | X | X | |
12-lead ECG | X | X | X | X | X | X | |
Inclusion/exclusion criteria | X | ||||||
Randomization to treatment groups | X | ||||||
Laboratory test |
X | X | X | X | X | X | |
Assessment of trial outcomes/adverse events | X | X | X | X | X | X |
HDL-C, high-density lipoprotein cholesterol; TG, triglyceride; HbA1c, glycosylated hemoglobin; eGFR, estimated glomerular filtration rate; AST, aspartate aminotransferase; ALT, alanine aminotransferase. Cardiovascular diseases include coronary artery disease, ischemic stroke, transient ischemic attack, carotid artery disease, and peripheral artery disease. Cardiovascular risk factor includes abdominal aortic aneurysm, duration of diabetes ≥10 years, age (men ≥45 years, women ≥55 years), family history of premature atherosclerotic cardiovascular disease, hypertension, smoking, low HDL-C level (<40 mg/dL), albuminuria, chronic kidney disease (eGFR <60 mL/min/1.73 m2), retinopathy, neuropathy, left ventricular hypertrophy.
ECG, electrocardiogram. Screening procedure and baseline measurements are conducted on the same day; Demographic information includes age, date of birth, sex, height, weight, waist circumference, smoking history, alcohol consumption, and physical activity level; Laboratory tests including hematology (red blood cell count, white blood cell [WBC] count, hemoglobin, hematocrit, platelet, WBC differential count, high-sensitivity C-reactive protein), blood chemistry tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase, creatinine phosphokinase, total bilirubin, creatinine), urinalysis (pH, specific gravity, protein, WBC), urine albumin/creatinine, blood glucose test (glycosylated hemoglobin, fasting plasma glucose, fasting insulin), lipid profile (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], triglyceride, non-HDL-C) will be measured at the site visits or recorded from electronic medical records.