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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
\- Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)
Korea University Ansan Hospital
Ansan, South Korea
LDL-C change rate (percent, %)
To compare LDL-C change rate (percent, %) between test and control group
Time frame: Baseline and 16 weeks
Triglyceride (TG) change rate (percent, %)
To compare Triglyceride (TG) change rate (percent,%)between test and control group
Time frame: Baseline and 16 weeks
Change rates (percent, %) of LDL-C and Triglyceride (TG)
To measure/compare Change rates (percent, %) of LDL-C and Triglyceride (TG) between test and control group
Time frame: Baseline and 4 weeks
Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C
To measure/compare Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C between test and control group
Time frame: Baseline, 4 weeks, and 16 weeks
Percent (%) of subjects with a 50% or more reduction in LDL-C level
To measure/compare Percent (%) of subjects with a 50% or more reduction in LDL-C level between test and control group
Time frame: 4 weeks and 16 weeks
Percent (%) of subjects with LDL-C below 70 mg/dL
To measure/compare Percent (%) of subjects with LDL-C below 70 mg/dL between test and control group
Time frame: 4 weeks and 16 weeks
Changes of lipoproteins (ApoA1, ApoB)
To measure/compare Changes of lipoproteins (ApoA1 (mg/dL), ApoB (mg/dL)) between test and control group
Time frame: Baseline and 16 weeks
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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
...and 16 more locations
Changes of lipoproteins (ApoB/ApoA1 ratio)
To measure/compare Changes of lipoproteins (ApoB/ApoA1 ratio) between test and control group
Time frame: Baseline and 16 weeks
Change of HOMA-IR
To measure/compare Change of HOMA-IR between test and control group
Time frame: Baseline and 16 weeks
Change of HbA1C (percentage, %)
To measure/compare Change of HbA1C (percentage, %) between test and control group
Time frame: Baseline, 4 weeks, and 16 weeks
Change (mg/dL) of Fasting Plasma Glucose (FPG)
To measure/compare Change (mg/dL) of Fasting Plasma Glucose (FPG) between test and control group
Time frame: Baseline, 4 weeks, and 16 weeks
Change (mg/dL) of hs-CRP
To measure/compare Change (mg/dL) of hs-CRP between test and control group
Time frame: 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
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
Time frame: 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)
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
Time frame: Baseline and 16 weeks
Adverse event
To measure/compare Adverse event between test and control group
Time frame: Baseline and 16 weeks
Blood pressure
To measure/compare Blood pressure between test and control group
Time frame: Baseline and 16 weeks
Pulse
To measure/compare Pulse between test and control group
Time frame: Baseline and 16 weeks
Electrocardiogram (12-lead ECG)
Number(%) of participants with Clinically Significant or Normal Electrocardiogram (12-lead ECG) findings after study drug administration
Time frame: -4 weeks and 16 weeks