Ignite Creation Date:
2024-05-06 @ 12:31 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01595789
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2012-05-08
Brief Title:
The Effect of Liraglutide on the Treatment of Coronary Artery Disease and Type 2 Diabetes
Sponsor:
Haugaard Steen Bendix MD DMSc
Organization:
Haugaard Steen Bendix MD DMSc
Study Overview
Official Title:
Adding Liraglutide to the Backbone Therapy of Biguanide in Patients With Coronary Artery Disease and Newly Diagnosed Type-2 Diabetes
Status:
COMPLETED
Status Verified Date:
2017-03
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:
AddHope2
Brief Summary:
The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1 GLP-1 analogue and metformin therapy on glucose metabolic and cardiovascular endpoints compared to metformin monotherapy in patients with coronary artery disease CAD and newly diagnosed type 2 diabetes T2D
It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD patients with T2D will improve beta-cell function left ventricular ejection fraction LVEF heart rate variability and lower 24h blood pressure among other selected endpoints
The present study on CAD patients with newly diagnosed T2D will address these selected endpoints during an investigator initiated randomized double blind crossover placebo-controlled 12 12 weeks intervention study with a 2 week wash-out period
It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD patients with T2D will improve beta-cell function left ventricular ejection fraction LVEF heart rate variability and lower 24h blood pressure among other selected endpoints
The present study on CAD patients with newly diagnosed T2D will address these selected endpoints during an investigator initiated randomized double blind crossover placebo-controlled 12 12 weeks intervention study with a 2 week wash-out period
Detailed Description:
The total study period for each patient will be 26 weeks 12 plus 12 weeks of intervention with a 2 week wash-out period
The endpoints will be evaluated at baseline week 0 at week 12 at week 14 following 2 weeks of wash-out and finally at week 26
The endpoints will be evaluated at baseline week 0 at week 12 at week 14 following 2 weeks of wash-out and finally at week 26
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-005405-78 | EUDRACT_NUMBER | None | None |