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

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

Interventions

DRUG

Dual-combination therapy

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

DRUG

Triple-combination therapy

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.

DEVICE

Dexcom G7, Pasta

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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd

  collaborator INDUSTRY

• Dong-A ST Co., Ltd.

  collaborator INDUSTRY

• HK inno.N Corporation

  collaborator INDUSTRY

• Daewoong Pharmaceutical Co. LTD.

  collaborator INDUSTRY

• Chong Kun Dang Pharmaceutical Corp.

  collaborator INDUSTRY

• Celltrion

  collaborator INDUSTRY

• Kakao Healthcare Corp.

  collaborator UNKNOWN

• Handok Inc.

  collaborator INDUSTRY

• Kyu Chang Won

  lead OTHER

Principal Investigators

• Kyu Chang Won, M.D., Ph.D. · Yeungnam University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-21

Primary Completion

2029-09-30

Completion

2029-09-30

Countries

• South Korea

Study Locations