NCT06627322Recruiting
A Registry-based Randomized Controlled Trial in Type 2 Diabetes With Cardiovascular Risk Factors (REMATCH)
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)
Source: ClinicalTrials.gov · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5950 (estimated)
- First submitted
- 26 Sept 2024
- Start date
- 21 Nov 2024
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Kyu Chang Won
- Diseases
- Type 2 diabetes
- NCT number
- NCT06627322
What you commit to
- Study type: Interventional
- Planned participants: 5950
- From 21 Nov 2024 to the primary completion date, 30 Sept 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of hospitalization for acute cardiovascular events within 3 months prior to the date of consent
- Contraindications for each assigned drug, as applicable
Other illness
- Type 1 diabetes
- Symptomatic heart failure (NYHA Class III or IV)
- Currently in active treatment for malignancy
Lab values
- Estimated GFR\<45 ml/min/1.73m²
- AST or ALT greater than 3 times the normal upper limit
Other
- Pregnant and nursing women
- If the investigator determines that assignment to the standard glycemic control arm raises ethical concerns
Who the study is looking for
- ≥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
- 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
- (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)
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yeungnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Not yet recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.