Dyslipidemia Associated With Type II Diabetes MellitusNCT07359105
Moderate-intensity Statin vs. Individualized LDL-C Target-based Therapy in Older Adults With Type 2 Diabetes (iTARGET-Elderly Study)
A study testing Moderate-intensity statin monotherapy and Ezetimibe or ezetimibe-statin combination therapy in people with Dyslipidemia Associated With Type II Diabetes Mellitus, run by Sin Gon Kim at 2 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Dyslipidemia Associated With Type II Diabetes Mellitus
- What is being tested?
- Moderate-intensity statin monotherapy and Ezetimibe or ezetimibe-statin combination therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,186 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 9 Mar 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Korea University ANAM Hospital
Seoul
- Not yet recruiting
Severance Hospital
Seoul
About this study
Official title: A Registry-based Randomized Controlled Trial of Moderate-intensity Statin Therapy vs. Individualized Low-density Lipoprotein Cholesterol Target-based Therapy for Primary Prevention of Cardiovascular Events in Patients 70 Years of Age or Older With Type 2 Diabetes (iTARGET-Elderly Study)
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.
- Being tested
- Moderate-intensity statin monotherapy, Ezetimibe or ezetimibe-statin combination therapy
- Keywords
- Dyslipidemia, T2D, Diabetes, Statins, iTARGET-Elderly, RRCT
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity statin monotherapyDrug
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.
Ezetimibe or ezetimibe-statin combination therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity statin monotherapy arm | Active comparator | Statin monotherapy with approved medications. Receives: 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. Receives: Drug: Ezetimibe or ezetimibe-statin combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 0, 3, 12, 24, 36 months
Serum lipid levels from baseline at each assessment time point
Measured: 0, 3, 12, 24, 36 months
Serum lipid changes from baseline at each assessment time point
Measured: 0, 3, 12, 24, 36 months
Patterns of study drug use
Measured: From baseline up to 36 months
Incidence rates and characteristics of adverse events, adverse drug reactions, and serious adverse events
Measured: From baseline up to 36 months
Incidence rates and characteristics of adverse events of special interest (AESI)
Adverse events of special interest (AESI): (1) Elevation of aminotransferase levels, (2) Rhabdomyolysis/myopathy, (3) Gastrointestinal problems
Measured: From baseline up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start9 Mar 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslipidemia Associated With Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sin Gon Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Hanmi Pharmaceutical Company Limited, Yuhan Corporation
- Responsible party
- Sponsor-investigator, Sin Gon Kim, Korea University Anam Hospital
- Investigators
- Sin Gon Kim, MD, Principal investigator, Korea University Anam HospitalBong-Soo Cha, MD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359105
- Sponsor's protocol ID
- 2025AN0165
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry-based Randomized Controlled Trial of Moderate-intensity Statin Therapy vs. Individualized Low-density Lipoprotein Cholesterol Target-based Therapy for Primary Prevention of Cardiovascular Events in Patients 70 Years of Age or Older With Type 2 Diabetes (iTARGET-Elderly Study)
- ClinicalTrials.gov ID
- NCT07359105
- Acronym / sponsor ID
- 2025AN0165
- Keywords
- Dyslipidemia, T2D, Diabetes, Statins, iTARGET-Elderly, RRCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,186 participants (estimated)
- Lead sponsor
- Sin Gon KimUniversity, hospital or other
- Collaborators
- Severance Hospital, Hanmi Pharmaceutical Company Limited, Yuhan Corporation
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity statin monotherapy arm | Active comparator | Drug: Moderate-intensity statin monotherapyStatin monotherapy with approved medications. |
| Individualized LDL-C target-based therapy arm | Experimental | Drug: Ezetimibe or ezetimibe-statin combination therapyThe 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-intensity statin monotherapyAtorvastatin 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. | Drug | Moderate-intensity statin monotherapy arm |
| Ezetimibe or ezetimibe-statin combination therapyTreatment 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. | Drug | Individualized LDL-C target-based therapy arm |
Primary outcome
Time from the date of randomization to the first occurrence of a major adverse cardiovascular event (MACE)
Time frame: 0, 3, 12, 24, 36 months
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.
7 secondary outcomes
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
Time frame: 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
Time frame: 0, 3, 12, 24, 36 months
Serum lipid levels from baseline at each assessment time point
Time frame: 0, 3, 12, 24, 36 months
Serum lipid changes from baseline at each assessment time point
Time frame: 0, 3, 12, 24, 36 months
Patterns of study drug use
Time frame: From baseline up to 36 months
Incidence rates and characteristics of adverse events, adverse drug reactions, and serious adverse events
Time frame: From baseline up to 36 months
Incidence rates and characteristics of adverse events of special interest (AESI)
Time frame: From baseline up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sin Gon Kim, MD principal investigator
Korea University Anam Hospital
Bong-Soo Cha, MD principal investigator
Severance Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity statin monotherapy and Ezetimibe or ezetimibe-statin combination therapy in people with Dyslipidemia Associated With Type II Diabetes Mellitus, run by Sin Gon Kim at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim (82-2-920-6791, aakmcaaec002@kumc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from the date of randomization to the first occurrence of a major adverse cardiovascular event (MACE) (time frame: 0, 3, 12, 24, 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.