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

NCT06627322 | Recruiting DMC

• 1 other identifier: YUMC 2023-08-009
• Study Type: interventional
• Target: 5,950
• Locations: 1 country
• Sites: 2

Brief Summary

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

Type 2 Diabetes

Keywords

Diabetes; T2D; T2DM; RRCT

Outcome Measures

Primary Outcomes (1)

• A composite of major adverse cardiovascular events (MACE) or diabetic microvascular events

  The time from the date of randomization to the first occurrence of any of the events or records in A\*\* and B\*\* as defined below. \[\*\*A.Major adverse cardiovascular events (MACEs): (1) Death from cardiovascular causes (2) Non-fatal stroke (3) Non-fatal myocardial infarction (4) Hospitalization due to unstable angina (5) Hospitalization due to heart failure (6) Hospitalization due to peripheral artery disease (7) Coronary or peripheral revascularization \*\*B.Diabetic microvascular events * B1. A composite of kidney events: 1. Death from kidney causes 2. Development of end-stage renal disease 3. Sustained decline in eGFR of 40% or more from baseline 4. Occurrence of marked albuminuria, * B2. A composite of eye events: 1. Development or progression of diabetic retinopathy (proliferative diabetic retinopathy or macular edema) 2. Blindness due to diabetic retinopathy 3. Surgical treatment of diabetic retinopathy or intravitreal injections\]

  6-month, 1-, 2-, 3-, 4-year after enrollment

Secondary Outcomes (9)

• Composite endpoint of cardiorenal events_#1

  6-month, 1-, 2-, 3-, 4-year after enrollment

• Composite endpoint of cardiorenal events_#2

  6-month, 1-, 2-, 3-, 4-year after enrollment

• Level of HbA1c (glycated haemoglobin)

  6-month, 1-, 2-, 3-, 4-year after enrollment

• The proportion of participants who exhibited a weight change (either gain or loss) of 10% or more

  6-month, 1-, 2-, 3-, 4-year after enrollment

• Change in waist circumference at each time point from baseline

  6-month, 1-, 2-, 3-, 4-year after enrollment

Study Arms (2)

Standard treatment arm (HbA1c 7.0% target)

ACTIVE COMPARATOR

Metformin/DPP-4i-based or Metformin/SGLT2i-based dual-combination therapy. Treatment and Follow-up : Maximum 4 years

Drug: Dual-combination therapy

Intensive treatment arm (HbA1c 6.0% target): plus real-time CGM

EXPERIMENTAL

Randomly assigned into 2 sub-groups Device: Dexcom G7 plus Kakaohealthcare Pasta. (Barozen Fit is also available.) Treatment and Follow-up : Maximum 4 years

Drug: Triple-combination therapy; Device: Dexcom G7, Pasta

Interventions

Dual-combination therapy DRUG

Group 1: Metformin/DPP-4i-based or Metformin/SGLT2i-based dual-combination therapy. Any oral antiglycemic drugs on the market.

Standard treatment arm (HbA1c 7.0% target)

Triple-combination therapy DRUG

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.

Intensive treatment arm (HbA1c 6.0% target): plus real-time CGM

Dexcom G7, Pasta DEVICE

Real-time continous glucose monitoring system (CGMS) Device (sensor): Dexcom G7 Device (software): Kakaohealthcare Pasta Barozen Fit is also available.

Intensive treatment arm (HbA1c 6.0% target): plus real-time CGM

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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:
• A. 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)

You may not qualify if:

• Type 1 diabetes
• Estimated GFR\<45 ml/min/1.73m²
• AST or ALT greater than 3 times the normal upper limit
• Symptomatic heart failure (NYHA Class III or IV)
• History of hospitalization for acute cardiovascular events within 3 months prior to the date of consent
• Currently in active treatment for malignancy
• Contraindications for each assigned drug, as applicable
• Pregnant and nursing women
• If the investigator determines that assignment to the standard glycemic control arm raises ethical concerns

Sponsors & Collaborators

• Kyu Chang Won: lead
• Boryung Pharmaceutical Co., Ltd: collaborator
• Dong-A ST Co., Ltd.: collaborator
• HK inno.N Corporation: collaborator
• Daewoong Pharmaceutical Co. LTD.: collaborator
• Chong Kun Dang Pharmaceutical Corp.: collaborator
• Celltrion: collaborator
• Kakao Healthcare Corp.: collaborator
• Handok Inc.: collaborator

Study Sites (2)

Yeungnam University Medical Center

Daegu, 42415, South Korea

NOT YET RECRUITING

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kyu Chang Won, M.D., Ph.D.

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyu Chang Won, M.D., Ph.D.

CONTACT

+82-53-620-3846; kcwon63@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: RRCT (Registry-based randomized controlled trial)

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 4, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)