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

ClinicalTrials.gov IDNCT06627322

PhaseNA

Enrollment5950

SponsorKyu Chang Won

Age19 Years and older

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes

About this 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.

Interventions

Drug: Dual-combination therapy — Group 1: Metformin/DPP-4i-based or Metformin/SGLT2i-based dual-combination therapy. Any oral antiglycemic drugs on the market.
Drug: Triple-combination therapy — 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.
Device: Dexcom G7, Pasta — Real-time continous glucose monitoring system (CGMS) Device (sensor): Dexcom G7 Device (software): Kakaohealthcare Pasta Barozen Fit is also available.

Primary outcomes

A composite of major adverse cardiovascular events (MACE) or diabetic microvascular events (6-month, 1-, 2-, 3-, 4-year after enrollment)

Eligibility information

Inclusion Criteria: 1. ≥19 years of age 2. Patient agreed to participate in the study and signed a written informed consent form 3. Type 2 diabetes (ADA criteria) 4. 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) 5. Any of the following: A. Patients who one or more of the following conditions 1. Coronary artery disease 2. Atherosclerotic ischemic stroke, transient ischemic attack, carotid artery disease, peripheral artery disease, abdominal aortic aneurysm 3. Prevalence of diabetes ≥10 years 4. Left ventricular hypertrophy 5. Albuminuria 6. Chronic kidney disease (eGFR\<60mL/min/1.73m²) 7. Diabetic Retinopathy 8. Diabetic neuropathy or B. Patients who have two or more of the following cardiovascular risk factors (1) 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) Exclusion Criteria: 1. Type 1 diabetes 2. Estimated GFR\<45 ml/min/1.73m² 3. AST or ALT greater than 3 times the normal upper limit 4. Symptomatic heart failure (NYHA Class III or IV) 5. History of hospitalization for acute cardiovascular events within 3 months prior to the date of consent 6. Currently in active treatment for malignancy 7. Contraindications for each assigned drug, as applicable 8. Pregnant and nursing women 9. If the investigator determines that assignment to the standard glycemic control arm raises ethical concerns

Study locations

Yeungnam University Medical Center, Daegu, 42415 South Korea
Korea University Anam Hospital, Seoul, 02841 South Korea

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.