RecruitingNot ApplicableNCT06627322

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)

Sponsor

Kyu Chang Won

Enrollment

5,950 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding a newer type of diabetes medication improves heart and kidney health in people with Type 2 diabetes who also have cardiovascular risk factors. **You may be eligible if...** - You are 19 years or older with Type 2 diabetes - Your HbA1c is between 7% and 10% on oral diabetes medicines - You have heart disease, kidney disease, diabetic complications, or multiple cardiovascular risk factors (like high blood pressure, high cholesterol, or obesity) **You may NOT be eligible if...** - You have Type 1 diabetes - Your kidney function is significantly reduced (eGFR below 45) - Your liver enzymes are very elevated - You have severe heart failure or were recently hospitalized for a heart event - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDual-combination therapy

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

DRUGTriple-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.

DEVICEDexcom G7, Pasta

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