Actively Recruiting
A Registry-based Randomized Controlled Trial in Type 2 Diabetes With Cardiovascular Risk Factors (REMATCH)
Led by Kyu Chang Won · Updated on 2025-04-24
5950
Participants Needed
2
Research Sites
253 weeks
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
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.
CONDITIONS
Official 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
- Signed informed consent to participate
- Diagnosis of type 2 diabetes according to ADA criteria
- HbA1c of 7.0% or higher and less than 10.0% while on monotherapy, dual-combination, or triple-combination oral antidiabetic therapies at submaximal doses
- Presence of one or more of the following: coronary artery disease, atherosclerotic ischemic stroke or related conditions, diabetes for 10 years or more, left ventricular hypertrophy, albuminuria, chronic kidney disease with eGFR less than 60 mL/min/1.73m², diabetic retinopathy, or diabetic neuropathy
- Alternatively, presence of two or more cardiovascular risk factors such as family history of early-onset atherosclerotic cardiovascular disease, hypertension, low HDL cholesterol, current smoking, or obesity (BMI ≥25 kg/m²)
You will not qualify if you...
- Diagnosis of type 1 diabetes
- Estimated glomerular filtration rate 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
- Hospitalization for acute cardiovascular events within 3 months prior to consent
- Active treatment for malignancy
- Contraindications to assigned study drugs
- Pregnant or nursing women
- Investigators' ethical concerns regarding assignment to the standard glycemic control arm
AI-Screening
AI-Powered Screening
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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.
CONTACT
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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