Phase
Condition
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Metabolic Disorders
Treatment
N/AClinical Study ID
Ages 40-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Screening (Visit 1) Inclusion Criteria
- Korean men and women aged 40 to 75
- Patients who have been diagnosed with type 2 diabetes based on clinical judgment andsatisfy diabetes diagnosis criteria
- Those who have no history of statin administration or who are receiving low- andmoderate-intensity statin, and who have the following laboratory values on an emptystomach
- Low density lipoprotein-cholesterol (LDL-C) ≥ 100 mg/dL (direct measurementresult)
- 200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
- Those with less than 9% HbA1C
- Those who voluntarily agreed to participate in this clinical trial and signed awritten ICF Randomization (Visit 2) Inclusion Criteria
- Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and withgood TLC by investigator's judgment
- LDL-C ≥ 70 mg/dL (direct measurement result) at baseline (visit 2)
- Triglyceride (TG) ≥ 150 mg/dL at baseline (visit 2)
Exclusion
Exclusion Criteria:
- Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) andingredients of IP
- Pregnant and lactating women, and women and men of childbearing potential who do notagree to conduct appropriate contraception during clinical trial
- Patients with Body Mass Index (BMI) < 15 kg/ m2 or > 35 kg/m2
- Persons with the following medical history or surgical/interventional history
- Atherosclerotic disease occurring within 24 weeks at screening
- Myopathy including rhabdomyolysis
- Patients who have had a history of drug or alcohol abuse, or who have met drug oralcohol abuse criteria within 1 year at screening
- Major mental illness (depression, bipolar disorder, etc.)
- Malignant tumor within 5 years at screening
- Persons with the following comorbidities and laboratory abnormalities
- CK ≥ 2 X ULN
- Patients with severe hepatopathy (AST or ALT > 5 X ULN)
- Patients with unexplained persistent ALT elevation opinion or active liverdisease
- TSH (Thyroid stimulating hormone) > 1.5 X ULN or those who do not maintain stablethyroid stimulating hormone level by investigator's judgment
- Uncontrolled hypertension (greater than sitBP 160/100 mmHg at screening)
- Renal disorder patients with severe renal failure (creatinine clearance (CLcr)
- Those who have the following history of drug administration within 3 months atscreening
- Non-statin lipid modulators
- Foods or drugs that affect lipid control
- Systemic steroids
- Those who are expected to administer contraindication drugs during clinical trial,including screening
- Those who have persistent history of drinking within 1 week at clinical trialparticipation or who are unable to perform TLC due to continuous drinking duringclinical trial
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency,or glucose-galactose malabsorptioin
- Those who received other IPs or investigational medical devices within 30 days atscreening
- Patients judged to be ineligible to participate in clinical trial by investigator'sdecision
Study Design
Study Description
Connect with a study center
Korea University Ansan Hospital
Ansan,
Korea, Republic ofActive - Recruiting
Soon Chun Hyang University Hospital Bucheon
Bucheon,
Korea, Republic ofSite Not Available
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon,
Korea, Republic ofSite Not Available
Soon Chun Hyang University Hospital Cheonan
Cheonan,
Korea, Republic ofActive - Recruiting
Keimyung University Dongsan Medical Center
Daegu,
Korea, Republic ofActive - Recruiting
Yeongnam University Medical Center
Daegu,
Korea, Republic ofSite Not Available
Eulji University Hospital
Daejeon,
Korea, Republic ofSite Not Available
Kyung Hee University Hosipital at Gangdong
Gangdong,
Korea, Republic ofSite Not Available
Inje University Ilsan Paik Hospital
Goyang-si,
Korea, Republic ofSite Not Available
Myongji Hospital
Goyang-si,
Korea, Republic ofSite Not Available
Hanyang University Guri Hospital
Guri-si,
Korea, Republic ofSite Not Available
Chosun University Hospital
Gwangju,
Korea, Republic ofSite Not Available
Hallym University Medical Center-Dongtan
Hwaseong-si,
Korea, Republic ofActive - Recruiting
Inha University Hospital
Inchon,
Korea, Republic ofSite Not Available
Pusan National University Hospital
Pusan,
Korea, Republic ofSite Not Available
Korea University Anam Hospital
Seoul,
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul,
Korea, Republic ofSite Not Available
Kyung Hee University Hospital
Seoul,
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Seoul St.Mary
Seoul,
Korea, Republic ofSite Not Available
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul,
Korea, Republic ofSite Not Available
Yonsei University Health System, Gangnam Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Yonsei University Health System, Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon,
Korea, Republic ofSite Not Available
The Catholic University of Korea, St. Vincent's Hospital
Suwon,
Korea, Republic ofSite Not Available
Gachon University, Donginchoen Gil Hospital
Sŏngnam,
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Sŏngnam,
Korea, Republic ofActive - Recruiting
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