Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Korea United Pharm. Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atmeg with Omethyl Cutielet | Experimental | Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) Omethyl Cutielet: Omega-3 2000mg (920mg as EPA ethyl ester, 760mg as DHA ethyl ester) once daily |
|
| Atmeg | Active Comparator | Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) |
|
| ezetimibe/atorvastatin 10/20 | Active Comparator | 1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3-Atorvastatin | Drug | Atmeg 2 capsules with 1 pack of Omethyl cutielet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carotid intima media thickness | maximum carotid IMT (mm) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area of carotid artery plaque | measured by ultrasound | 24 weeks |
| Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics | changes of non-calcified plaque volume (mm3) |
Not provided
Inclusion Criteria:
Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
Male or female of 20 years or over
Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL
Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction
Creatinine ≤1.8 mg/dL
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Lim | Contact | +82-31-787-7035 | limsoo@snu.ac.kr | |
| Minji Sohn | Contact | rainbowmjs@naver.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNUBH | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Omega 3-Atorvastatin | Drug | Atmeg 2 capsules |
|
|
| Atorvastatin-Ezetimibe | Drug | ezetimibe/atorvastatin 10/20 mg |
|
| 24 weeks |
| Glucose homeostasis | changes of HbA1c (%) | 24 weeks |
| Lipid metabolism | TG concentration, HDL-cholesterol concentration | 24 weeks |
| Bioelectrical Impedance Analysis | Body composition of fat mass (kg) | 24 weeks |
| Proteinuria | albumin-to-creatinine ratio (mg/g) | 24 weeks |
| Changes of gut microbiota | measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species | 24 weeks |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D050197 | Atherosclerosis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C583267 | liptruzet |
Not provided
Not provided
Not provided