Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03313752
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2017-10-04
Brief Title:
Effects of SGLT2 Inhibition on Myocardial Insulin Sensitivity
Sponsor:
Andrea Giaccari
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Study on the Effect of Dapagliflozin on Myocardial Insulin Sensitivity and Perfusion
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
DapaHeart
Brief Summary:
A Phase III single-centre randomized 2-arm parallel-group double blind placebo-controlled study consisting of a screening phase Days -14 to -1 a 4-week double-blind placebo-controlled treatment phase and a 4-week follow-up phase
Subjects Type 2 diabetic patients and coronary artery diseases CAD not requiring revascularization or underwent percutaneous coronary intervention PCI but clinically stable at time of screening visit with suboptimal glycaemic control HbA1c 70-85 on their current anti-hyperglycaemic regimen
Subjects will be randomized in a 11 ratio to dapagliflozin or placebo
Subjects will undergo screening assessment in the 14-day period preceding administration of the first dose of study drug on Day 1
The primary Objective is to assess the effect of dapagliflozin on myocardial insulin sensitivity The Secondary Objective is to assess global heart function and metabolic systemic effects of dapagliflozin and glycemic control
The study aims to enroll patients with type 2 diabetes with suboptimal glycemic control and with coronary artery diseases CAD not requiring revascularization or underwent percutaneous coronary intervention PCI but clinically stable who have already undergone under routine cardiological assessment a positron emission tomography PET 13NH3 scan in order to assess the cardiovascular function Thus the study aims to assess whether the improvement in cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal clinical practice according to Standards of Care
Subjects Type 2 diabetic patients and coronary artery diseases CAD not requiring revascularization or underwent percutaneous coronary intervention PCI but clinically stable at time of screening visit with suboptimal glycaemic control HbA1c 70-85 on their current anti-hyperglycaemic regimen
Subjects will be randomized in a 11 ratio to dapagliflozin or placebo
Subjects will undergo screening assessment in the 14-day period preceding administration of the first dose of study drug on Day 1
The primary Objective is to assess the effect of dapagliflozin on myocardial insulin sensitivity The Secondary Objective is to assess global heart function and metabolic systemic effects of dapagliflozin and glycemic control
The study aims to enroll patients with type 2 diabetes with suboptimal glycemic control and with coronary artery diseases CAD not requiring revascularization or underwent percutaneous coronary intervention PCI but clinically stable who have already undergone under routine cardiological assessment a positron emission tomography PET 13NH3 scan in order to assess the cardiovascular function Thus the study aims to assess whether the improvement in cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal clinical practice according to Standards of Care
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None