Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642623
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Open Registry-based Randomized Controlled Investigator Initiated Trial of EnavogliflozinENVlo to EvaLuate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients ENVELOP Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ENVELOP
Brief Summary:
The novel sodium-glucose cotransporter-2 SGLT2 inhibitor enavogliflozin effectively reduces glycated hemoglobin HbA1c levels and body weight without increasing the risk of serious adverse events However its long-term clinical benefits concerning cardiovascular and renal outcomes have yet to be thoroughly studied This study is an investigator-initiated multicenter randomized pragmatic open-label active-controlled non-inferiority trial Eligible participants are adults aged 19 or older with type 2 diabetes who have a history of or are at risk for cardiovascular disease A total of 2862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits such as dapagliflozin or empagliflozin The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular and renal events This trial aims to determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with type 2 diabetes and cardiovascular risk factors It will also clarify role of enavogliflozin in preventing vascular complications in this patient population
Detailed Description:
The ENVELOP study aims to assess cardiorenal outcomes following enavogliflozin administration compared with dapagliflozin or empagliflozin in Korean patients with type 2 diabetes representing the first large-scale SGLT2 inhibitor outcome study targeting this population
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