Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313008
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-09
Brief Title:
Empagliflozin Versus Vildagliptin in CAD Patients With T2DM
Sponsor:
Damanhour University
Organization:
Damanhour University
Study Overview
Official Title:
A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes EMBA-VILDA-Response Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We compared the cardioprotective effects of empagliflozin an SGLT2 inhibitor with those of vildagliptin a dipeptidyl peptidase-4 DPP-4 inhibitor focusing on various inflammatory biomarkers lipid profile and cardiac function in patients with type 2 diabetes mellitus T2DM
Detailed Description:
This was a prospective randomized double-dummy parallel-group trial that enrolled 120 patients with T2DM The patients were randomized 1 1 for 12-week administration of empagliflozin or vildagliptin by using consecutive ascending randomization numbers in the treatment blocks allocated to each study site The randomization was stratified by the presence or absence of statin and oral antidiabetic therapy The randomization list was produced using an automated random number generator
Clinical parameters assessment of atrial myocardial function LVEF LA diameter glycemic and lipid profile adiponectin high-sensitivity C-reactive protein and Sortilin levels will be determined at baseline and after the 6 months of treatment period
Patient compliance was evaluated by the counting of pills by a physician at selected time-points In addition patients were provided with individual diary cards to record administration of the study medication on a daily basis These cards were checked regularly by site staff
The study will be approved by the local ethics committee and was conducted in accordance with the Declaration of Helsinki and its amendments All included patients provided written informed consent
Clinical parameters assessment of atrial myocardial function LVEF LA diameter glycemic and lipid profile adiponectin high-sensitivity C-reactive protein and Sortilin levels will be determined at baseline and after the 6 months of treatment period
Patient compliance was evaluated by the counting of pills by a physician at selected time-points In addition patients were provided with individual diary cards to record administration of the study medication on a daily basis These cards were checked regularly by site staff
The study will be approved by the local ethics committee and was conducted in accordance with the Declaration of Helsinki and its amendments All included patients provided written informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None