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Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

ConditionsDyslipidemiasAtherosclerosisDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg

Disqualifiers

Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL

Uncontrolled hypertension: SBP >180 mmHg or DBP >110 mmHg

Severe renal dysfunction: eGFR <30 mL/min/1.73m2

AST/ALT >120/120 or chronic liver disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Omega 3-Atorvastatin

    Drug

    Atmeg 2 capsules with 1 pack of Omethyl cutielet

  • Omega 3-Atorvastatin

    Drug

    Atmeg 2 capsules

  • Atorvastatin-Ezetimibe

    Drug

    ezetimibe/atorvastatin 10/20 mg

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Atmeg with Omethyl CutieletExperimental treatment 1 intervention
Group B: AtmegActive comparator 1 intervention
Group C: ezetimibe/atorvastatin 10/20Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Carotid intima media thickness

maximum carotid IMT (mm)

Time frame
24 weeks

Secondary outcomes

1

Area of carotid artery plaque

measured by ultrasound

Time frame
24 weeks
2

Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics

changes of non-calcified plaque volume (mm3)

Time frame
24 weeks
3

Glucose homeostasis

changes of HbA1c (%)

Time frame
24 weeks
4

Lipid metabolism

TG concentration, HDL-cholesterol concentration

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

Korea United Pharm. Inc.

Collaborator

Source ClinicalTrials.gov
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