Evaluating glycemic control approaches in type 2 diabetes with cardiovascular risks
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)
This study is testing if aiming for a lower blood sugar level can help people with type 2 diabetes and heart risks avoid serious health problems better than the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5950 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yeungnam University Hospital Academic / other |
| Locations | 2 sites (Daegu and 1 other locations) |
| Trial ID | NCT06627322 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized trial investigates the effects of intensive glycemic control targeting a HbA1c of 6.0% compared to standard control at 7.0% in individuals with type 2 diabetes and cardiovascular risk factors. The study will enroll 5,950 participants who meet specific eligibility criteria, including elevated HbA1c levels and existing cardiovascular conditions. Participants will be randomly assigned to either the intensive or standard treatment arm, and outcomes will be tracked using various health registries and electronic medical records. The primary endpoint is the time to major adverse cardiovascular and diabetic microvascular events.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with type 2 diabetes, elevated HbA1c levels, and cardiovascular risk factors.
Not a fit: Patients who do not have type 2 diabetes or those with HbA1c levels below 7.0% may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective glycemic control strategies for patients with type 2 diabetes, potentially reducing the risk of serious complications.
How similar studies have performed: Previous studies have shown mixed results regarding intensive glycemic control, but this approach utilizing newer antidiabetic drugs is promising and may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Daegu and 1 other locations
- Yeungnam University Medical Center — Daegu, South Korea (Not_yet_recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Kyu Chang Won, M.D., Ph.D. — Yeungnam University Hospital
- Study coordinator: Kyu Chang Won, M.D., Ph.D.
- Email: kcwon63@gmail.com
- Phone: +82-53-620-3846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.