New study tests if personalized cholesterol targets beat standard statins for seniors with diabetes

NCT ID NCT07359105

Disease control Sponsor: Sin Gon Kim Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a personalized approach to lowering 'bad' cholesterol (LDL-C) works better than standard moderate-dose statins for preventing first heart attacks, strokes, or related events in people aged 70 and older with type 2 diabetes. About 2,186 participants will be randomly assigned to either moderate statin therapy or a treatment plan aimed at reaching a specific LDL target (using ezetimibe if needed). The goal is to see which strategy better prevents major cardiovascular events over up to 3 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: statins (atorvastatin or rosuvastatin) and ezetimibe
What this could lead to: If successful, this could show that tailoring cholesterol treatment to individual targets is better than standard statin therapy for preventing first heart attacks or strokes in older adults with diabetes.
What could go wrong: This is a registry-based trial, not a classic double-blind study, so results may be less definitive. The benefit of intensive LDL lowering in this age group is still unproven, and the trial may not show a clear advantage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,186 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Dyslipidemias type 2 diabetes mellitus cardiovascular disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dyslipidemia associated with type II diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New study tests if personalized cholesterol targets beat standard statins for seniors with diabetes

What the study statuses mean