Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627322
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
A Registry-based Randomized Controlled Trial in Type 2 Diabetes with Cardiovascular Risk Factors REMATCH
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMATCH
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
Detailed Description:
This is a multicenter prospective registry-based randomized open-label active-comparator controlled trial involving 5776 eligible participants with T2D cardiovascular risk factors and elevated HbA1c 70 Participants will be randomly assigned to either intensive arm targeting 60 of HbA1c or standard arm targeting 70 of HbA1c The primary end point is the time to development of a composite of major adverse cardiovascular and diabetic microvascular events
This study is designed as registry-based randomized clinical trial RRCT which adheres to the characteristics of both randomized clinical trial and registry-based prospective observational study The participants will be randomly assigned into either intensive glycemic control arm or standard glycemic control arm and the outcomes and variables will be recorded by multiple registries including hospital electronic medical records nationwide health registry the national health insurance service NHIS and Korean Statistical Information Service registry
This study is designed as registry-based randomized clinical trial RRCT which adheres to the characteristics of both randomized clinical trial and registry-based prospective observational study The participants will be randomly assigned into either intensive glycemic control arm or standard glycemic control arm and the outcomes and variables will be recorded by multiple registries including hospital electronic medical records nationwide health registry the national health insurance service NHIS and Korean Statistical Information Service registry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None