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

NCT04700436 | Completed Phase 4

• 1 other identifier: REMBRANDT
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 26

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).

Conditions

Endocrine System Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• LDL-C change rate (percent, %)

  To compare LDL-C change rate (percent, %) between test and control group

  Baseline and 16 weeks

• Triglyceride (TG) change rate (percent, %)

  To compare Triglyceride (TG) change rate (percent,%)between test and control group

  Baseline and 16 weeks

Secondary Outcomes (16)

• Change rates (percent, %) of LDL-C and Triglyceride (TG)

  Baseline and 4 weeks

• Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C

  Baseline, 4 weeks, and 16 weeks

• Percent (%) of subjects with a 50% or more reduction in LDL-C level

  4 weeks and 16 weeks

• Percent (%) of subjects with LDL-C below 70 mg/dL

  4 weeks and 16 weeks

• Changes of lipoproteins (ApoA1, ApoB)

  Baseline and 16 weeks

Study Arms (2)

Test group

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

Subject administered with Suvast tablet 10 mg (Rosuvastatin 10 mg)

Drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)

Interventions

Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) DRUG

Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)

Test group

Suvast tablet 10 mg (Rosuvastatin 10 mg) DRUG

\- Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)

Control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Korean men and women aged 40 to 75
• Patients who have been diagnosed with type 2 diabetes based on clinical judgment and satisfy diabetes diagnosis criteria
• Who have the following laboratory values on an empty stomach
• Patients with no prior statin therapy
• Low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are \< 400 mg/dL)
• mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
• Patients currently receiving low- or moderate-intensity statin therapy
• Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are \< 400 mg/dL)
• 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 a written ICF
• \) Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment

You may not qualify if:

• Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
• Pregnant and lactating women, and women and men of childbearing potential who do not agree 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 or alcohol 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 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Gangnam Severance Hospital: collaborator

Study Sites (26)

Korea University Ansan Hospital

Ansan, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeongnam University Medical Center

Daegu, South Korea

Location

Eulji University Hospital

Daejeon, South Korea

Location

Kyung Hee University Hosipital at Gangdong

Gangdong, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, South Korea

Location

Hanyang University Guri Hospital

Guri-si, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Hallym University Medical Center-Dongtan

Hwaseong-si, South Korea

Location

Inha University Hospital

Inchon, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St.Mary

Seoul, South Korea

Location

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

Seoul, South Korea

Location

Yonsei University Health System, Gangnam Severance Hospital

Seoul, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Gachon University, Donginchoen Gil Hospital

Sŏngnam, South Korea

Location

Seoul National University Bundang Hospital

Sŏngnam, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

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

Suwon, South Korea

Location

MeSH Terms

Conditions

Endocrine System Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

Ezetimibe; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Kyong Soo Park, Dr.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: January 7, 2021
• Study Start: January 3, 2020
• Primary Completion: May 28, 2021
• Study Completion: February 13, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (26)