Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia
- Conditions
- Nutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasDiabetes Mellitus, Type 2
- Interventions
- Drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
- Registration Number
- NCT04700436
- Lead Sponsor
- Seoul National University Hospital
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
Screening (Visit 1) Inclusion Criteria
-
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
-
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
-
Those with less than 9% HbA1C
-
Those who voluntarily agreed to participate in this clinical trial and signed a written ICF
Randomization (Visit 2) Inclusion Criteria
- Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment
- LDL-C ≥ 70 mg/dL (direct measurement result) at baseline (visit 2)
- Triglyceride (TG) ≥ 150 mg/dL at baseline (visit 2)
-
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)
- Renal disorder patients with severe renal failure (creatinine clearance (CLcr)
-
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
-
Those who are expected to administer contraindication drugs during clinical trial, including screening
-
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
-
Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin
-
Those who received other IPs or investigational medical devices within 30 days at screening
-
Patients judged to be ineligible to participate in clinical trial by investigator's decision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) Subject administered with Suvast tablet 10 mg (Rosuvastatin 10 mg) Test group Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) Subject administered with Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
- Primary Outcome Measures
Name Time Method Triglyceride (TG) change rate (percent, %) Baseline and 16 weeks To compare Triglyceride (TG) change rate (percent,%)between test and control group
LDL-C change rate (percent, %) Baseline and 16 weeks To compare LDL-C change rate (percent, %) between test and control group
- Secondary Outcome Measures
Name Time Method Change rates (percent, %) of LDL-C and Triglyceride (TG) Baseline and 4 weeks To measure/compare Change rates (percent, %) of LDL-C and Triglyceride (TG) between test and control group
Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C 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
Changes of lipoproteins (ApoA1, ApoB) Baseline and 16 weeks To measure/compare Changes of lipoproteins (ApoA1 (mg/dL), ApoB (mg/dL)) between test and control group
Changes of lipoproteins (ApoB/ApoA1 ratio) Baseline and 16 weeks To measure/compare Changes of lipoproteins (ApoB/ApoA1 ratio) between test and control group
Percent (%) of subjects with a 50% or more reduction in LDL-C level 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
Percent (%) of subjects with LDL-C below 70 mg/dL 4 weeks and 16 weeks To measure/compare Percent (%) of subjects with LDL-C below 70 mg/dL between test and control group
Change of HOMA-IR Baseline and 16 weeks To measure/compare Change of HOMA-IR between test and control group
Change of HbA1C (percentage, %) Baseline, 4 weeks, and 16 weeks To measure/compare Change of HbA1C (percentage, %) between test and control group
Change (mg/dL) of Fasting Plasma Glucose (FPG) Baseline, 4 weeks, and 16 weeks To measure/compare Change (mg/dL) of Fasting Plasma Glucose (FPG) between test and control group
Change (mg/dL) of hs-CRP Baseline and 16 weeks To measure/compare Change (mg/dL) of hs-CRP between test and control group
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) 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
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 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
Adverse event Baseline and 16 weeks To measure/compare Adverse event between test and control group
Blood pressure Baseline and 16 weeks To measure/compare Blood pressure between test and control group
Pulse Baseline and 16 weeks To measure/compare Pulse between test and control group
Electrocardiogram (12-lead ECG) -4 weeks and 16 weeks Number(%) of participants with Clinically Significant or Normal Electrocardiogram (12-lead ECG) findings after study drug administration
Trial Locations
- Locations (28)
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Inha University Hospital
🇰🇷Inchon, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Sŏngnam, Korea, Republic of
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Gachon University, Donginchoen Gil Hospital
🇰🇷Sŏngnam, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System, Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang-si, Korea, Republic of
Myongji Hospital
🇰🇷Goyang-si, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Hallym University Medical Center-Dongtan
🇰🇷Hwaseong-si, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Yeongnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
The Catholic University of Korea, Bucheon St. Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of
Kyung Hee University Hosipital at Gangdong
🇰🇷Gangdong, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of