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Type 2 DiabetesREMATCHNCT06627322

A Registry-based Randomized Controlled Trial in Type 2 Diabetes With Cardiovascular Risk Factors (REMATCH)

A study testing Dual-combination therapy, Triple-combination therapy and Dexcom G7, Pasta in people with Type 2 Diabetes, run by Kyu Chang Won at 2 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Glycemic control is a mainstay of diabetes management to reduce the risk of microvascular complications and cardiovascular outcomes in people with type 2 diabetes (T2D). However, intensive control to near-normal glycated hemoglobin (HbA1c) yielded complex results in previous landmark trials. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Dual-combination therapy, Triple-combination therapy and Dexcom G7, Pasta
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,950 participants
Where
2 sitesSouth Korea
Study dates
21 Nov 2024to 30 Sep 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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥19 years of age
  • Patient agreed to participate in the study and signed a written informed consent form
  • Type 2 diabetes (ADA criteria)
  • HbA1c≥7.0% and \<10.0% in patients receiving monotherapy, dual-combination therapy, or triple-combination therapy (when the submaximal dose was administered) with oral antidiabetic drugs (OADs)
  • Any of the following:
  • Patients who one or more of the following conditions
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  • Coronary artery disease
  • Atherosclerotic ischemic stroke, transient ischemic attack, carotid artery disease, peripheral artery disease, abdominal aortic aneurysm
  • Prevalence of diabetes ≥10 years
  • Left ventricular hypertrophy
  • Albuminuria
  • Chronic kidney disease (eGFR\<60mL/min/1.73m²)
  • Diabetic Retinopathy
  • Diabetic neuropathy or B. Patients who have two or more of the following cardiovascular risk factors
  • Family history of early-onset ASCVD (first-degree relatives with disease before age 55 for men and before age 65 for women) (2) Hypertension (on medication or with SBP≥140 mm Hg or DBP≥90 mm Hg) (3) Low HDL cholesterol concentration (\<40 mg/dL) (4) Current smoker (5) Obese (BMI≥25 kg/m²)

Who cannot join

  • Type 1 diabetes
  • Estimated GFR\<45 ml/min/1.73m²
  • AST or ALT greater than 3 times the normal upper limit
  • Symptomatic heart failure (NYHA Class III or IV)
  • History of hospitalization for acute cardiovascular events within 3 months prior to the date of consent
  • Currently in active treatment for malignancy
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  • Contraindications for each assigned drug, as applicable
  • Pregnant and nursing women
  • If the investigator determines that assignment to the standard glycemic control arm raises ethical concerns

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kyu Chang Won, M.D., Ph.D. contact

+82-53-620-3846

kcwon63@gmail.com

South Korea2 sites, 2 recruiting

  • Yeungnam University Medical Center

    Daegu, 42415

    Won, M.D., Ph.D., +82-53-620-3846, kcwon63@gmail.com

    Kyu Chang Won, M.D., Ph.D.

    Not yet recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Sin Gon Kim, M.D., Ph.D., +82-2-920-6791, k50367@korea.ac.kr

    Sin Gon Kim, M.D., Ph.D.

    Recruiting

Other trials in South Korea

About this study

Official title: Registry Based Randomized Controlled Trial of Multiple Combination Strategies of Intensive Glycemic Control to Reduce a Composite of Macrovascular and Microvascular Events in Type 2 Diabetes With Cardiovascular Risk Factors (REMATCH Study)

Glycemic control is a mainstay of diabetes management to reduce the risk of microvascular complications and cardiovascular outcomes in people with type 2 diabetes (T2D). However, intensive control to near-normal glycated hemoglobin (HbA1c) yielded complex results in previous landmark trials. Potential risks of intensive glycemic control, such as hypoglycemia and weight gain, may partly contributed to the possible harms associated with this approach. Recent advances in diabetes management with development of newer antidiabetic drugs which minimize possible harms of intensive glycemic control as well as reduce cardiorenal risks enabled safer glycemic reduction. Thus, this randomized trial aims to evaluate the effects of near normalization of HbA1c with novel approaches on microvascular complications and cardiovascular outcomes in people with T2D.

Read the detailed description

This is a multicenter, prospective, registry-based, randomized, open-label, active-comparator controlled trial involving 5,950 eligible participants with T2D, cardiovascular risk factors, and elevated HbA1c (≥7.0%). Participants will be randomly assigned to either intensive arm (targeting 6.0% of HbA1c) or standard arm (targeting 7.0% of HbA1c). The primary end point is the time to development of a composite of major adverse cardiovascular and diabetic microvascular events.

This study is designed as registry-based randomized clinical trial (RRCT), which adheres to the characteristics of both randomized clinical trial and registry-based prospective observational study. The participants will be randomly assigned into either intensive glycemic control arm or standard glycemic control arm, and the outcomes and variables will be recorded by multiple registries including hospital electronic medical records, nationwide health registry (the national health insurance service, NHIS), and Korean Statistical Information Service registry.

Conditions
Type 2 Diabetes
Being tested
Dual-combination therapy, Triple-combination therapy, Dexcom G7, Pasta
Keywords
Diabetes, T2D, T2DM, RRCT
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual-combination therapyDrug

    Group 1: Metformin/DPP-4i-based or Metformin/SGLT2i-based dual-combination therapy. Any oral antiglycemic drugs on the market.

  • Triple-combination therapyDrug

    Group 2: Metformin/SGLT2i/DPP-4i-based triple-cobmination therapy, or Group 3: Metformin/SGLT2i/Thiazolidinedione-based triple-cobmination therapy Any oral antiglycemic drugs on the market.

  • Dexcom G7, PastaDevice

    Real-time continous glucose monitoring system (CGMS) Device (sensor): Dexcom G7 Device (software): Kakaohealthcare Pasta Barozen Fit is also available.

Study groups in NCT06627322
Study groupRoleWhat they receive
Standard treatment arm (HbA1c 7.0% target)Active comparatorMetformin/DPP-4i-based or Metformin/SGLT2i-based dual-combination therapy. Treatment and Follow-up : Maximum 4 years
Receives: Drug: Dual-combination therapy
Intensive treatment arm (HbA1c 6.0% target): plus real-time CGMExperimentalRandomly assigned into 2 sub-groups Device: Dexcom G7 plus Kakaohealthcare Pasta. (Barozen Fit is also available.) Treatment and Follow-up : Maximum 4 years
Receives: Drug: Triple-combination therapy; Device: Dexcom G7, Pasta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A composite of major adverse cardiovascular events (MACE) or diabetic microvascular events

    The time from the date of randomization to the first occurrence of any of the events or records in A and B as defined below.

    [**A.Major adverse cardiovascular events (MACEs): (1) Death from cardiovascular causes (2) Non-fatal stroke (3) Non-fatal myocardial infarction (4) Hospitalization due to unstable angina (5) Hospitalization due to heart failure (6) Hospitalization due to peripheral artery disease (7) Coronary or peripheral revascularization

    **B.Diabetic microvascular events

    • B1. A composite of kidney events:
    1. Death from kidney causes
    2. Development of end-stage renal disease
    3. Sustained decline in eGFR of 40% or more from baseline
    4. Occurrence of marked albuminuria,
    • B2. A composite of eye events:
    1. Development or progression of diabetic retinopathy (proliferative diabetic retinopathy or macular edema)
    2. Blindness due to diabetic retinopathy
    3. Surgical treatment of diabetic retinopathy or intravitreal injections]

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

Secondary outcomes (9)

  1. Composite endpoint of cardiorenal events_#1

    Time from the date of randomization to the first occurrence of any of the events or histories of A or B defined in the protocol. [A. Major cardiovascular events : (1) Death from cardiovascular cause, (2) Non-fatal stroke, (3) Non-fatal myocardial infarction, (4) hospitalization due to heart failure; B. Major Kidney Events: (1) Death from kidney causes, (2) Development of end-stage renal disease, (3) Sustained decline in eGFR of 40% or more from baseline]

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

  2. Composite endpoint of cardiorenal events_#2

    Time from the date of randomization to the first occurrence of any of the events or histories of A [is equal to the "A" defined in the primary endpoint] or B [is equal to the "B1" defined in the primary endpoint] defined in the protocol.

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

  3. Level of HbA1c (glycated haemoglobin)

    The level is a crucial indicator for managing Type 2 Diabetes. It is used to assess long-term blood sugar control and the effectiveness of your diabetes management strategies.

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

  4. The proportion of participants who exhibited a weight change (either gain or loss) of 10% or more

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

  5. Change in waist circumference at each time point from baseline

    Abdominal obesity is assessed by measuring waist circumference. Long-term follow-up studies have reported that abdominal obesity increases the risk of type 2 diabetes, cardiovascular disease, and death, even after correction for body mass index (BMI).

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

  6. Change in estimated glomerular filtration rate (eGFR) from baseline

    Glomerular filtration rate (GFR) is a measure of how well your kidneys are functioning. It estimates the amount of blood that pass through the glomeruli (the tiny filters in the kidneys) each minute. Estimated GFR will be calcuated by CKD-EPI formula in this study.

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

  7. Change in lipid panel

    Lipid panel: blood total cholesterol, LDL-cholesterol, HDL-cholesterol, Tryglycerides.

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

  8. Change in urine albumin to creatinine ratio (UACR) from baseline

    The urine albumin to creatinine ration (UACR) is a test that measures the amount of albumin (a typie of protein) in the urine relative to the amount of creatinine. It is used to assess your kidney function, particularly to detect early signs of kidney damage or disease.

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

  9. Safety endopoints

    Incidence rate and charateristics (causality, seriousness, severity, outcomes, action taken etc.) of adverse events, serious adverse events, and adverse events of special interest (acute kidney injury, hypoglycemia, acute hyperglycemic complications, GI symptoms, ,urogenital infection, edema, weight gain)

    Measured: 6-month, 1-, 2-, 3-, 4-year after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start21 Nov 2024
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

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
RRCT (Registry-based randomized controlled trial)
Masking
None (open label)
Enrolment
5,950 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06627322
Sponsor's protocol ID
YUMC 2023-08-009
Acronym
REMATCH
Status last verified
Apr 2025
First submitted
26 Sep 2024
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dual-combination therapy, Triple-combination therapy and Dexcom G7, Pasta in people with Type 2 Diabetes, run by Kyu Chang Won 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 15 inclusion and 9 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 24 Apr 2025. 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 Kyu Chang Won, M.D., Ph.D. (+82-53-620-3846, kcwon63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A composite of major adverse cardiovascular events (MACE) or diabetic microvascular events (time frame: 6-month, 1-, 2-, 3-, 4-year after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06627322.

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 24 Apr 2025.

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REMATCH Clinical Trial NCT06627322 | AzTrials