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| Name | Class |
|---|---|
| Gangnam Severance Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Subject administered with 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 4 weeks |
| Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C |
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Inclusion Criteria:
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
Who have the following laboratory values on an empty stomach
Patients with no prior statin therapy
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
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
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:
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
Persons with the following comorbidities and laboratory abnormalities
Those who have the following history of drug administration within 3 months at screening
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
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| Name | Affiliation | Role |
|---|---|---|
| Kyong Soo Park, Dr. | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | South Korea | ||||
| Soon Chun Hyang University Hospital Bucheon |
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| Suvast tablet 10 mg (Rosuvastatin 10 mg) | Drug | - Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg) |
|
To measure/compare Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C between test and control group |
| 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 | 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 | 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 | Baseline and 16 weeks |
| Changes of lipoproteins (ApoB/ApoA1 ratio) | To measure/compare Changes of lipoproteins (ApoB/ApoA1 ratio) between test and control group | Baseline and 16 weeks |
| Change of HOMA-IR | To measure/compare Change of HOMA-IR between test and control group | Baseline and 16 weeks |
| Change of HbA1C (percentage, %) | To measure/compare Change of HbA1C (percentage, %) between test and control group | 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 | 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 | 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 | 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 | Baseline and 16 weeks |
| Adverse event | To measure/compare Adverse event between test and control group | Baseline and 16 weeks |
| Blood pressure | To measure/compare Blood pressure between test and control group | Baseline and 16 weeks |
| Pulse | To measure/compare Pulse between test and control group | 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 | -4 weeks and 16 weeks |
| 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 |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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