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

January 6, 2021 updated by: Kyong Soo Park, Seoul National University Hospital

A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of EzetimiBe/Rosuvastatin Diabetic Dislipidemia With Hypertriglyceridaemia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kyong Soo Park, Dr.
  • Phone Number: +82-2-2072-2946
  • Email: kspark@snu.ac.kr

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
      • Bucheon, Korea, Republic of
        • Not yet recruiting
        • Soon Chun Hyang University Hospital Bucheon
        • Contact:
      • Bucheon, Korea, Republic of
        • Not yet recruiting
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
        • Contact:
      • Cheonan, Korea, Republic of
        • Recruiting
        • Soon Chun Hyang University Hospital Cheonan
        • Contact:
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
      • Daegu, Korea, Republic of
        • Not yet recruiting
        • Yeongnam University Medical Center
        • Contact:
      • Daejeon, Korea, Republic of
        • Not yet recruiting
        • Eulji University Hospital
        • Contact:
      • Gangdong, Korea, Republic of
        • Not yet recruiting
        • Kyung Hee university Hosipital at Gangdong
        • Contact:
      • Goyang-si, Korea, Republic of
        • Not yet recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
      • Goyang-si, Korea, Republic of
        • Not yet recruiting
        • Myongji Hospital
        • Contact:
      • Guri-si, Korea, Republic of
        • Not yet recruiting
        • Hanyang University GURI Hospital
        • Contact:
      • Gwangju, Korea, Republic of
        • Not yet recruiting
        • Chosun university hospital
        • Contact:
      • Hwaseong-si, Korea, Republic of
        • Recruiting
        • Hallym University Medical Center-Dongtan
        • Contact:
      • Inchon, Korea, Republic of
        • Not yet recruiting
        • Inha University Hospital
        • Contact:
      • Pusan, Korea, Republic of
        • Not yet recruiting
        • Pusan National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Kyung Hee University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • The Catholic University of Korea, Seoul St.Mary
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Yonsei University Health System, Gangnam Severance Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Yonsei University Health system, Severance Hospital
        • Contact:
      • Suwon, Korea, Republic of
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:
      • Suwon, Korea, Republic of
        • Not yet recruiting
        • The Catholic university of Korea, St. Vincent's Hospital
        • Contact:
      • Sŏngnam, Korea, Republic of
        • Not yet recruiting
        • Gachon University, Donginchoen Gil Hospital
        • Contact:
      • Sŏngnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 and satisfy diabetes diagnosis criteria

  3. Those who have no history of statin administration or who are receiving low- and moderate-intensity statin, and who have the following laboratory values on an empty stomach

    • Low density lipoprotein-cholesterol (LDL-C) ≥ 100 mg/dL (direct measurement result)
    • 200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
  4. Those with less than 9% HbA1C
  5. Those who voluntarily agreed to participate in this clinical trial and signed a written ICF

Randomization (Visit 2) Inclusion Criteria

  1. Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment
  2. LDL-C ≥ 70 mg/dL (direct measurement result) at baseline (visit 2)
  3. Triglyceride (TG) ≥ 150 mg/dL at baseline (visit 2)

Exclusion Criteria:

  1. Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
  2. Pregnant and lactating women, and women and men of childbearing potential who do not agree 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 or alcohol abuse criteria within 1 year at screening
    • Major mental illness (depression, bipolar disorder, etc.)
    • Malignant tumor within 5 years at screening

  5. 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 liver disease
    • TSH (Thyroid stimulating hormone) > 1.5 X ULN or those who do not maintain stable thyroid 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)

  6. Those who have the following history of drug administration within 3 months at screening

    • Non-statin lipid modulators
    • Foods or drugs that affect lipid control
    • Systemic steroids
  7. Those who are expected to administer contraindication drugs during clinical trial, including screening
  8. Those who have persistent history of drinking within 1 week at clinical trial participation or who are unable to perform TLC due to continuous drinking during clinical trial
  9. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin
  10. Those who received other IPs or investigational medical devices within 30 days at screening
  11. Patients judged to be ineligible to participate in clinical trial by investigator's decision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
Subject administered with Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
Drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)

IP

  • Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
  • Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)
Other Names:
  • Suvast tablet 10 mg (Rosuvastatin 10 mg)
Active Comparator: Control group
Subject administered with Suvast tablet 10 mg (Rosuvastatin 10 mg)
Drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)

IP

  • Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
  • Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)
Other Names:
  • Suvast tablet 10 mg (Rosuvastatin 10 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-C change rate (percent, %)
Time Frame: Baseline and 16 weeks
To compare LDL-C change rate (percent, %) between test and control group
Baseline and 16 weeks
Triglyceride (TG) change rate (percent, %)
Time Frame: Baseline and 16 weeks
To compare Triglyceride (TG) change rate (percent,%)between test and control group
Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change rates (percent, %) of LDL-C and Triglyceride (TG)
Time Frame: Baseline and 4 weeks
To measure/compare Change rates (percent, %) of LDL-C and Triglyceride (TG) between test and control group
Baseline and 4 weeks
Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C
Time Frame: Baseline, 4 weeks, and 16 weeks
To measure/compare Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C between test and control group
Baseline, 4 weeks, and 16 weeks
Percent (%) of subjects with a 50% or more reduction in LDL-C level
Time Frame: 4 weeks and 16 weeks
To measure/compare Percent (%) of subjects with a 50% or more reduction in LDL-C level between test and control group
4 weeks and 16 weeks
Percent (%) of subjects with LDL-C below 70 mg/dL
Time Frame: 4 weeks and 16 weeks
To measure/compare Percent (%) of subjects with LDL-C below 70 mg/dL between test and control group
4 weeks and 16 weeks
Changes of lipoproteins (ApoA1, ApoB)
Time Frame: Baseline and 16 weeks
To measure/compare Changes of lipoproteins (ApoA1 (mg/dL), ApoB (mg/dL)) between test and control group
Baseline and 16 weeks
Changes of lipoproteins (ApoB/ApoA1 ratio)
Time Frame: Baseline and 16 weeks
To measure/compare Changes of lipoproteins (ApoB/ApoA1 ratio) between test and control group
Baseline and 16 weeks
Change of HOMA-IR
Time Frame: Baseline and 16 weeks
To measure/compare Change of HOMA-IR between test and control group
Baseline and 16 weeks
Change of HbA1C (percentage, %)
Time Frame: Baseline, 4 weeks, and 16 weeks
To measure/compare Change of HbA1C (percentage, %) between test and control group
Baseline, 4 weeks, and 16 weeks
Change (mg/dL) of Fasting Plasma Glucose (FPG)
Time Frame: Baseline, 4 weeks, and 16 weeks
To measure/compare Change (mg/dL) of Fasting Plasma Glucose (FPG) between test and control group
Baseline, 4 weeks, and 16 weeks
Change (mg/dL) of hs-CRP
Time Frame: Baseline and 16 weeks
To measure/compare Change (mg/dL) of hs-CRP between test and control group
Baseline and 16 weeks
Changes of plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL) levels at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC
Time Frame: Baseline and 16 weeks
To measure/compare Changes of plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL) levels at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC between test and control group
Baseline and 16 weeks
On the graphs at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC, total Area Under the Curve (tAUC) of each plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL)
Time Frame: Baseline and 16 weeks
To measure/compare On the graphs at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC, total Area Under the Curve (tAUC) of each plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL) between test and control group
Baseline and 16 weeks
Adverse event
Time Frame: Baseline and 16 weeks
To measure/compare Adverse event between test and control group
Baseline and 16 weeks
Blood pressure
Time Frame: Baseline and 16 weeks
To measure/compare Blood pressure between test and control group
Baseline and 16 weeks
Pulse
Time Frame: Baseline and 16 weeks
To measure/compare Pulse between test and control group
Baseline and 16 weeks
Electrocardiogram (12-lead ECG)
Time Frame: -4 weeks and 16 weeks
Number(%) of participants with Clinically Significant or Normal Electrocardiogram (12-lead ECG) findings after study drug administration
-4 weeks and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Gangnam Severance Hospital

Investigators

  • Principal Investigator: Kyong Soo Park, Dr., Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2020

Primary Completion (Anticipated)

May 28, 2021

Study Completion (Anticipated)

November 26, 2021

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMBRANDT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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