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

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ClinicalTrials.gov Identifier: NCT04700436
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
Gangnam Severance Hospital
Information provided by (Responsible Party):
Kyong Soo Park, Seoul National University Hospital

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Endocrine System Diseases Nutritional and Metabolic Diseases Diabetes Mellitus, Type 2 Dyslipidemias Drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 3, 2020
Estimated Primary Completion Date : May 28, 2021
Estimated Study Completion Date : November 26, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Suvast tablet 10 mg (Rosuvastatin 10 mg)


Outcome Measures
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Primary Outcome Measures :
  1. LDL-C change rate (percent, %) [ Time Frame: Baseline and 16 weeks ]
    To compare LDL-C change rate (percent, %) between test and control group

  2. Triglyceride (TG) change rate (percent, %) [ Time Frame: Baseline and 16 weeks ]
    To compare Triglyceride (TG) change rate (percent,%)between test and control group


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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. 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

  5. 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

  6. 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

  7. Change of HOMA-IR [ Time Frame: Baseline and 16 weeks ]
    To measure/compare Change of HOMA-IR between test and control group

  8. Change of HbA1C (percentage, %) [ Time Frame: Baseline, 4 weeks, and 16 weeks ]
    To measure/compare Change of HbA1C (percentage, %) between test and control group

  9. 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

  10. 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

  11. 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

  12. 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

  13. Adverse event [ Time Frame: Baseline and 16 weeks ]
    To measure/compare Adverse event between test and control group

  14. Blood pressure [ Time Frame: Baseline and 16 weeks ]
    To measure/compare Blood pressure between test and control group

  15. Pulse [ Time Frame: Baseline and 16 weeks ]
    To measure/compare Pulse between test and control group

  16. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700436


Contacts
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Contact: Kyong Soo Park, Dr. +82-2-2072-2946 kspark@snu.ac.kr

Locations
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Sponsors and Collaborators
Seoul National University Hospital
Gangnam Severance Hospital
Investigators
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Principal Investigator: Kyong Soo Park, Dr. Principal Investigator
More Information
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Responsible Party: Kyong Soo Park, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04700436    
Other Study ID Numbers: REMBRANDT
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Dyslipidemias
Metabolic Diseases
Hypertriglyceridemia
Endocrine System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Hyperlipidemias
 Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors