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

NCT07359105 | Recruiting DMC

• 1 other identifier: 2025AN0165
• Study Type: interventional
• Target: 2,186
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus

Keywords

Dyslipidemia; T2D; Diabetes; Statins; iTARGET-Elderly; RRCT

Outcome Measures

Primary Outcomes (1)

• Time from the date of randomization to the first occurrence of a major adverse cardiovascular event (MACE)

  Major adverse cardiovascular event (MACE) includes death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to heart failure, coronary revascularization, or all-cause death.

  0, 3, 12, 24, 36 months

Secondary Outcomes (7)

• Time from the date of randomization to the first hospitalization due to the following events or to the first occurrence of such events, whichever occurs earlier : (1) ischemic heart disease, (2) cerebrovascular disease, (3) heart failure, (4) peripheral

  0, 3, 12, 24, 36 months

• Time from the date of randomization to the first occurrence of all-cause hospitalization or all-cause death, whichever occurs first

  0, 3, 12, 24, 36 months

• Serum lipid levels from baseline at each assessment time point

  0, 3, 12, 24, 36 months

• Serum lipid changes from baseline at each assessment time point

  0, 3, 12, 24, 36 months

• Patterns of study drug use

  From baseline up to 36 months

Study Arms (2)

Moderate-intensity statin monotherapy arm

ACTIVE COMPARATOR

Statin monotherapy with approved medications.

Drug: Moderate-intensity statin monotherapy

Individualized LDL-C target-based therapy arm

EXPERIMENTAL

The investigator will establish individualized LDL-C targets (\<55 mg/dL or \<70 mg/dL or \<100 mg/dL) by considering each patient's cardiovascular risk, life expectancy, risk of adverse drug reactions, comorbidities, and personal preferences. The decision-making process will be shared with the patient to ensure that individual needs are addressed.

Drug: Ezetimibe or ezetimibe-statin combination therapy

Interventions

Ezetimibe or ezetimibe-statin combination therapy DRUG

Treatment will consist of non-pharmacological interventions or marketed medications, including low-dose statins (atorvastatin 5 mg or 10 mg, rosuvastatin 2.5 mg or 5 mg) in combination with ezetimibe 10 mg, or fixed-dose combinations (rosuvamibe 10/2.5 mg, atorvabmibe 10/5 mg, or Rosuzet 10/2.5 mg), for up to 3 years. If the pre-specified LDL-C target is not achieved or drug intolerance occurs, adjustments in dosage or medication will be made.

Individualized LDL-C target-based therapy arm

Moderate-intensity statin monotherapy DRUG

Atorvastatin 10 mg, 20 mg, or 40 mg, or rosuvastatin 5 mg, 10 mg, or 20 mg will be administered for up to 3 years. If the LDL-C is ≥100 mg/dL, the investigator may adjust the statin intensity based on the patient's health status.

Moderate-intensity statin monotherapy arm

Eligibility Criteria

• Age: 70 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• Sin Gon Kim: lead
• Severance Hospital: collaborator
• Hanmi Pharmaceutical Company Limited: collaborator
• Yuhan Corporation: collaborator

Study Sites (2)

Korea University ANAM Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sin Gon Kim, MD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Bong-Soo Cha, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim

CONTACT

82-2-920-6791; aakmcaaec002@kumc.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professior, Department of Endocrinology and metabolism, Korea University Anam Hospital, South Korea

Model Details: Eligible patients will be randomly assigned in a 1:1 ratio at Visit 1, using the Interactive Web Response System (IWRS), to either the moderate-intensity statin monotherapy arm or the individualized LDL-C target-based therapy arm.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)