Purpose of this Study
We are doing this study to learn more about how 2 different classes of diabetes medications help lower the risk of heart disease. The types of diabetes medications that have been shown to reduce the risk of new or worsening heart disease are SGLT2 inhibitors and GLP-1 receptor agonists. We don't know which of these drugs might be preferable to reduce heart disease risk for diabetes patients, and we hope this study can help us find out which drug(s) may be the most appropriate for most patients.
Who Can Participate?
Eligibility
Adults with type 2 diabetes who:<ul>
<li>Are ages 40+ and have had a heart attack, or a stroke, or have had stents placed to open their blood vessels; OR</li>
<li>Are ages 60+ and have hemoglobin AIC above 8, or have chronic kidney disease, or who smoke</li></ul>
For more information about this study, contact the study team at <a href= "mailto: chad.harrell@duke.edu">chad.harrell@duke.edu.</a>
<li>Are ages 40+ and have had a heart attack, or a stroke, or have had stents placed to open their blood vessels; OR</li>
<li>Are ages 60+ and have hemoglobin AIC above 8, or have chronic kidney disease, or who smoke</li></ul>
For more information about this study, contact the study team at <a href= "mailto: chad.harrell@duke.edu">chad.harrell@duke.edu.</a>
Age Range
40-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to either:<ul>
<li>Take an SGLT2 inhibitor; OR</li>
<li>Take a GLP-1 receptor agonist</li></ul>
SGLT2 inhibitors include the following medications: Jardiance®, Farxiga®, and Invokana®.
GLP-1 receptor agonists include the following medications: Victoza®, Trulicity®, Ozempic®, and Rybelsus®.
All drugs that are used in this study are FDA-approved for the treatment of type 2 diabetes.
<li>Take an SGLT2 inhibitor; OR</li>
<li>Take a GLP-1 receptor agonist</li></ul>
SGLT2 inhibitors include the following medications: Jardiance®, Farxiga®, and Invokana®.
GLP-1 receptor agonists include the following medications: Victoza®, Trulicity®, Ozempic®, and Rybelsus®.
All drugs that are used in this study are FDA-approved for the treatment of type 2 diabetes.
Locations
Remote/online
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes
Study Website
Principal Investigator
William
Jones
Protocol Number
PRO00111165
NCT ID
NCT05390892
Phase
III
Enrollment Status
Open to Enrollment