Welcome to PRECIDENTD!

Thank you for your interest in PRECIDENTD. In this study, people with diabetes are partnering with doctors and study teams to help advance our understanding of diabetes medications that lower the risk of heart disease.

Having type 2 diabetes doubles your risk for heart disease.

There are two classes of diabetes medications that have been shown to reduce that risk, SGLT2 inhibitors and GLP-1 receptor agonists. It is not known how these classes compare to each other.

What’s the goal of this study?

To learn more about the only two classes of diabetes medications shown to reduce risk of heart disease for people with type 2 diabetes.

We don’t know which medication class works better.

Who can participate in this study?

People with type 2 diabetes who are:

Over age 40 and have had a heart attack, stroke, or stents to open their blood vessels.

Over age 60 with A1C above 8, chronic kidney disease, or who smoke.

What does the study involve?

Our study team will work with your regular health care provider to fit the study medication into your usual diabetes care. Your current diabetes medications may be adjusted.

Visits & Surveys

First visit in-person or by video conference. This will help make sure the medicines are safe and affordable for you. If you agree to participate, you will complete questionnaires, and be assigned your medication.

Follow-up visit or call with study team two months later.

One survey per year by phone and online between the yearly visits.

One in-person or video conference visit per year.

Medications

All study medications are approved by the FDA to treat type 2 diabetes.

SGLT2 inhibitors such as Jardiance, Farxiga, Invokana

GLP-1 receptor agonists such as Victoza, Trulicity, Ozempic, Rybelsus

A computer will randomly assign you to take:
You can choose the medication within the class assigned to you. This choice may be based on your insurance coverage or your preference.

Our study team will send prescriptions to your usual pharmacy. You will pick up the prescriptions as you do your other prescriptions.

Medications and lab tests will be billed to your insurance company. Our study team will help assess your insurance coverage.

Timeline

This study lasts through 2029 because we want to see what the long-term effects of the medications are on important outcomes like heart attack and stroke.

What are the rewards?

What are the risks?

These medications can lower blood sugar, lower A1C, help with weight loss, and prevent heart problems.

You will be paid $500 for each year that you take part in the study.

Most common side effects are genital yeast infections for SGLT2 inhibitor and nausea for GLP-1 receptor agonists.

Most GLP-1 medications involve weekly injections with a small pen needle.

Questions?

Study team contact(s): (833) 879-0139 | PRECIDENTDCCC@BWH.harvard.edu

Mass General Brigham Institutional Review Board:
toll free: 877-992-4724  •  email: adviser@advarra.com