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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• ≥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)

Locations
Other Locations
Republic of Korea
Yeungnam University Medical Center
NOT_YET_RECRUITING
Daegu
Korea University Anam Hospital
RECRUITING
Seoul
Contact Information
Primary
Kyu Chang Won, M.D., Ph.D.
kcwon63@gmail.com
+82-53-620-3846
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 5950
Treatments
Active_comparator: Standard treatment arm (HbA1c 7.0% target)
Metformin/DPP-4i-based or Metformin/SGLT2i-based dual-combination therapy. Treatment and Follow-up : Maximum 4 years
Experimental: Intensive treatment arm (HbA1c 6.0% target): plus real-time CGM
Randomly assigned into 2 sub-groups Device: Dexcom G7 plus Kakaohealthcare Pasta. (Barozen Fit is also available.) Treatment and Follow-up : Maximum 4 years
Related Therapeutic Areas
Sponsors
Collaborators: Chong Kun Dang Pharmaceutical Corp., Dong-A ST Co., Ltd., Handok Inc., Celltrion, Kakao Healthcare Corp., HK inno.N Corporation, Boryung Pharmaceutical Co., Ltd, Daewoong Pharmaceutical Co. LTD.
Leads: Kyu Chang Won

This content was sourced from clinicaltrials.gov