Actively Recruiting
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)
Led by Kyu Chang Won · Updated on 2025-04-24
5950
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kyu Chang Won
Lead Sponsor
B
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of near normalization of glycated hemoglobin (HbA1c) on microvascular complications and cardiovascular outcomes in people with type 2 diabetes (T2D) who have cardiovascular risk factors and elevated HbA1c levels. This trial aims to compare intensive glycemic control targeting 6.0% HbA1c versus standard control targeting 7.0% HbA1c. The study is a multicenter, prospective, registry-based, randomized, open-label, active-comparator controlled trial enrolling 5,950 participants. It uses a combination of randomized clinical trial and registry-based observational study methods to assess outcomes through multiple health registries and electronic medical records. Participants will be randomly assigned to either an intensive glycemic control arm or a standard control arm. The intensive group receives treatment aiming for HbA1c of 6.0%, supported by real-time continuous glucose monitoring devices such as Dexcom G7 with Kakaohealthcare Pasta software or Barozen Fit. Both groups receive dual-combination therapy with metformin plus either DPP-4 inhibitors or SGLT2 inhibitors, with some participants possibly receiving triple-combination therapy involving additional drugs. Treatment and follow-up last up to four years. During the study, participants undergo regular assessments at 6 months and annually up to 4 years. Researchers monitor cardiovascular events, diabetic microvascular complications, HbA1c levels, weight changes, waist circumference, kidney function, lipid profiles, urine albumin-to-creatinine ratio, and safety outcomes. Data are collected via hospital records, national health registries, and statistical services. The primary outcome is the time until a major adverse cardiovascular or diabetic microvascular event occurs. This comprehensive monitoring seeks to understand how intensive glycemic control affects long-term health in T2D with cardiovascular risks.
CONDITIONS
Brief Title
A Registry-based Randomized Controlled Trial in Type 2 Diabetes With Cardiovascular Risk Factors (REMATCH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 19 years of age or older
- Patient agrees to participate and signs informed consent
- Diagnosed with type 2 diabetes according to ADA criteria
- HbA1c 7.0% or higher and less than 10.0% while on monotherapy, dual, or triple oral antidiabetic drugs
- Has one or more of the following: coronary artery disease, ischemic stroke or related vascular diseases, diabetes duration of 10 years or more, left ventricular hypertrophy, albuminuria, chronic kidney disease (eGFR less than 60 mL/min/1.73m2), diabetic retinopathy, diabetic neuropathy
- Or has two or more cardiovascular risk factors: family history of early atherosclerotic cardiovascular disease, hypertension, low HDL cholesterol, current smoker, or obesity (BMI 25 kg/m2 or higher)
You will not qualify if you...
- Type 1 diabetes
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73m2
- Liver enzymes (AST or ALT) greater than three times the normal upper limit
- Symptomatic heart failure classified as NYHA Class III or IV
- Recent hospitalization for acute cardiovascular events within 3 months before consent
- Currently receiving active treatment for cancer
- Contraindications to assigned study drugs
- Pregnant or nursing women
- If assignment to standard glycemic control arm raises ethical concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants are randomly assigned to intensive or standard glycemic control therapies using oral antidiabetic drugs. Some participants also use a continuous glucose monitoring device during treatment.
Visits at 6 months, 1 year, 2 years, 3 years, and 4 years after enrollment
Trial Site Locations
Total: 2 locations
1
Yeungnam University Medical Center
Daegu, South Korea, 42415
Not Yet Recruiting
2
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
Research Team
K
Kyu Chang Won, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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