Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia

Last updated: January 6, 2021
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes Mellitus, Type 2

Hypertriglyceridemia

Metabolic Disorders

Treatment

N/A

Clinical Study ID

NCT04700436
REMBRANDT
  • Ages 40-75
  • All Genders

Study Summary

To compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG > 200 mg/dL).

Eligibility Criteria

Inclusion

Inclusion Criteria: Screening (Visit 1) Inclusion Criteria

  1. Korean men and women aged 40 to 75
  2. Patients who have been diagnosed with type 2 diabetes based on clinical judgment andsatisfy diabetes diagnosis criteria
  3. 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
  1. Those with less than 9% HbA1C
  2. Those who voluntarily agreed to participate in this clinical trial and signed awritten ICF Randomization (Visit 2) Inclusion Criteria
  3. Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and withgood TLC by investigator's judgment
  4. LDL-C ≥ 70 mg/dL (direct measurement result) at baseline (visit 2)
  5. Triglyceride (TG) ≥ 150 mg/dL at baseline (visit 2)

Exclusion

Exclusion Criteria:

  1. Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) andingredients of IP
  2. Pregnant and lactating women, and women and men of childbearing potential who do notagree to conduct appropriate contraception during clinical trial
  3. Patients with Body Mass Index (BMI) < 15 kg/ m2 or > 35 kg/m2
  4. 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
  1. 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)
  1. 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
  1. Those who are expected to administer contraindication drugs during clinical trial,including screening
  2. 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
  3. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency,or glucose-galactose malabsorptioin
  4. Those who received other IPs or investigational medical devices within 30 days atscreening
  5. Patients judged to be ineligible to participate in clinical trial by investigator'sdecision

Study Design

Total Participants: 240
Study Start date:
January 03, 2020
Estimated Completion Date:
November 26, 2021

Study Description

The purpose of this study is to compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG > 200 mg/dL).

Connect with a study center

  • Korea University Ansan Hospital

    Ansan,
    Korea, Republic of

    Active - Recruiting

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    Bucheon,
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan,
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Yeongnam University Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Eulji University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hosipital at Gangdong

    Gangdong,
    Korea, Republic of

    Site Not Available

  • Inje University Ilsan Paik Hospital

    Goyang-si,
    Korea, Republic of

    Site Not Available

  • Myongji Hospital

    Goyang-si,
    Korea, Republic of

    Site Not Available

  • Hanyang University Guri Hospital

    Guri-si,
    Korea, Republic of

    Site Not Available

  • Chosun University Hospital

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Hallym University Medical Center-Dongtan

    Hwaseong-si,
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Inchon,
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Pusan,
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St.Mary

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System, Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System, Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

  • Gachon University, Donginchoen Gil Hospital

    Sŏngnam,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Sŏngnam,
    Korea, Republic of

    Active - Recruiting

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