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

NCT ID: NCT04700436

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2024-02-13

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).

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

Subject administered with Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Control group

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

Group Type: ACTIVE_COMPARATOR

Suvast tablet 10 mg (Rosuvastatin 10 mg)

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Suvast tablet 10 mg (Rosuvastatin 10 mg)

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

Intervention Type: DRUG

Eligibility Criteria

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. 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)
• 200 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)
• 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

1) Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment

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)<30 mL/min

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo Heon Kwak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyong Soo Park, Dr.

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Korea University Ansan Hospital

Ansan, , South Korea

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Yeongnam University Medical Center

Daegu, , South Korea

Eulji University Hospital

Daejeon, , South Korea

Kyung Hee University Hosipital at Gangdong

Gangdong, , South Korea

Inje University Ilsan Paik Hospital

Goyang-si, , South Korea

Hanyang University Guri Hospital

Guri-si, , South Korea

Chosun University Hospital

Gwangju, , South Korea

Hallym University Medical Center-Dongtan

Hwaseong-si, , South Korea

Inha University Hospital

Inchon, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

The Catholic University of Korea, Seoul St.Mary

Seoul, , South Korea

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

Seoul, , South Korea

Yonsei University Health System, Gangnam Severance Hospital

Seoul, , South Korea

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Gachon University, Donginchoen Gil Hospital

Sŏngnam, , South Korea

Seoul National University Bundang Hospital

Sŏngnam, , South Korea

Ajou University Hospital

Suwon, , South Korea

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

Suwon, , South Korea

Countries

South Korea

Other Identifiers

REMBRANDT

Identifier Type: -

Identifier Source: org_study_id