Diabetes Mellitus, Type 2, Dyslipidemias, Endocrine System Diseases, Nutritional and Metabolic Diseases
Conditions
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).
Interventions
DRUGRosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
DRUGSuvast tablet 10 mg (Rosuvastatin 10 mg)
\- Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)
Sponsors
Gangnam Severance Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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. 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 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C change rate (percent, %) | Baseline and 16 weeks | To compare LDL-C change rate (percent, %) between test and control group |
| Triglyceride (TG) change rate (percent, %) | Baseline and 16 weeks | To compare Triglyceride (TG) change rate (percent,%)between test and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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 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 |
| 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 |
| 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 |
| Change (mg/dL) of hs-CRP | Baseline and 16 weeks | To measure/compare Change (mg/dL) of hs-CRP 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 |
Countries
South Korea
Outcome results
None listed