Moderate-intensity Statin vs. Individualized LDL-C Target-based Therapy in Older Adults With Type 2 Diabetes (iTARGET-Elderly Study)

Recruiting now · Not applicable

Conditions studied: Dyslipidemia Associated With Type II Diabetes Mellitus

In brief

Statins are the cornerstone of cardiovascular disease (CVD) prevention through the lowering of low-density lipoprotein cholesterol (LDL-C). While the benefits of intensive LDL-C lowering are well-established for secondary prevention, evidence remains insufficient for primary prevention in the elderly-specifically for individuals aged 70 years or older with type 2 diabetes who have no prior history of atherosclerotic cardiovascular events. Current guidelines generally recommend moderate-intensity statins for this population based on extrapolated data. However, there is a significant evidence gap regarding whether these older adults, who have not yet experienced a cardiovascular event, derive the same risk-benefit ratio from pharmacological intervention as younger or secondary prevention groups. Furthermore, while ezetimibe (alone or in combination) is an effective alternative for patients with established disease, its efficacy as a primary prevention strategy in older diabetic patients has not been rigorously confirmed through randomized controlled trials (RCTs). Therefore, this study specifically focuses on the primary prevention setting, aiming to determine whether individualized LDL-C target-based therapy is non-inferior to standard moderate-intensity statin therapy in preventing first-time cardiovascular events among older patients with type 2 diabetes.

Key facts

Study ID

NCT07359105

Run by

Sin Gon Kim

People needed

2186

Starts

2026-03-09

Expected to finish

2029-12-31

Last updated by the study team

2026-03-10

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• Korea University ANAM Hospital — Seoul, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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