Moderate-intensity statin versus individualized LDL-C target therapy for people 70 or older with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares moderate-intensity statin monotherapy against individualized LDL‑C target–based therapy, which may include ezetimibe alone or in combination with statin, in adults aged 70 years or older with type 2 diabetes and no prior atherosclerotic cardiovascular disease. Eligible participants are either untreated with LDL‑C ≥100 mg/dL or are on current lipid‑lowering therapy without an LDL‑C limit. Participants receive the assigned approach and are followed for changes in LDL‑C as well as for cardiovascular events and safety outcomes. The study is conducted at major hospitals in Seoul, South Korea.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provision of written informed consent to participate in the study by the patient or his/her legally authorized representative after receiving and understanding a detailed explanation of the study
* Adults aged 70 years or older
* Diagnosed with type 2 diabetes or currently receiving antidiabetic medication, without a history or presence of cardiovascular disease
* Either: (1) LDL-C≥100 mg/dL if not receiving lipid-lowering therapy, or (2) currently receiving lipid-lowering therapy (in this case, LDL-C level not restricted)

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Documented history of atherosclerotic cardiovascular disease at screening, confirmed clinically or by imaging: (1) myocardial infarction; (2) coronary revascularization; (3) currently receiving treatment for acute coronary syndrome; (4) history of ischemic stroke; (5) aortic aneurysm; (6) peripheral arterial disease
* Currently undergoing cancer treatment
* Severe disease requiring recurrent hospitalization
* Frailty (defined as a score ≥3 on the Korean FRAIL questionnaire), or any condition significantly limiting self-care
* AST or ALT \>3 × ULN, at screening (however, patients will be eligible if repeat testing at the time of randomization shows levels \<3 × ULN), or liver cirrhosis
* Contraindications to study drugs
* Pregnant or breastfeeding women

Where it's running

• Korea University ANAM Hospital
  Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Principal investigator: Sin Gon Kim, MD — Korea University Anam Hospital
• Study coordinator: Kim
• Email: aakmcaaec002@kumc.or.kr
• Phone: 82-2-920-6791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.