Project Summary

Heart disease is one of the major causes of illness and death in type 2 diabetes mellitus. Type 2 diabetes affects over 32 million Americans. Of this group, approximately 20 million people also have heart disease or are at very high risk for heart disease. Recent large studies have shown that two new classes of diabetes medications, called sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA), reduce heart attack, stroke, kidney problems, and death in people with type 2 diabetes and heart disease or high heart disease risk. However, it is not clear which medication class is better for people with these health conditions, or whether the combination would work better than each medication alone. The medications are expensive and cause different side effects, so it is important to find out which people benefit most from which class of medications, whether these two classes of medications work better in combination, and who is likely to have side effects.

In order to answer these questions, the project team proposes a randomized trial called PRECIDENTD (PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes). In this trial, 9,000 diverse adults with type 2 diabetes and heart disease or high heart disease risk who decide to enroll will be assigned by randomization (like the flip of a coin) to one of three treatment groups: an SGLT2i, a GLP-1 RA, or both. Eligible participants will be recruited from a combination of sites participating in PCORnet®, the National Patient-Centered Clinical Research Network, and external sites. The study will identify potentially eligible patients through cohort identification queries using a computable phenotype and the PCORnet® Common Data Model (CDM). Participants will be recruited through outreach from study teams at the health center where they have been receiving their usual diabetes care, in partnership with their usual diabetes care providers. They will be followed by the study team, which will collaborate in their care with their usual diabetes care providers, for an average of 3.7 years. The study aims to determine whether SGLT2i, GLP-1 RA, or the combination is most effective at reducing major health events, such as heart attack, stroke, kidney problems, and death. The study also aims to determine the number of serious side effects in each treatment group and will ask participants about whether they can take the medications, how satisfied they are with the medications, and their overall health and quality of life. These outcomes will be tracked through queries of the electronic health record data using the PCORnet CDM and through participant report. Participants will be asked to have an in-person visit with the study team to enroll, three months after enrollment, and every year that they are in the study after enrollment, up to a maximum of 5.5 years. Participants will also be asked to speak on the telephone with study team members every six months between yearly visits and to complete surveys through a secure website, on the telephone, or in person, according to their preference.

To ensure this project generates the right information for people with type 2 diabetes and their diabetes care providers, the team will ask patient and healthcare provider stakeholders to partner with the study leadership team to finalize the trial questions and plans. Patient stakeholders will join the study leadership team and steering committee as research partners. In addition, a larger group of patient stakeholders will meet regularly throughout the project to advise and consult on all aspects of the project, from how the study is conducted to interpretation of the findings to sharing the results. The team will ensure that it works with stakeholders and enrolls participants from racial and ethnic groups with high diabetes prevalence, many of which have also historically been excluded from diabetes research. The team will also engage healthcare provider stakeholders who will help make sure the project is integrated into usual care and that the findings make sense to frontline providers and their patients and are shared widely.

The results of PRECIDENTD will help the approximately 20 million Americans with type 2 diabetes and heart disease or high heart disease risk, their families, and their healthcare providers decide which type of diabetes medication is best for their specific combination of medical conditions, preferences, and goals.

Project Information

Brendan Everett, MD, MPH
Robert J. Glynn, PhD, Sc.D
Brigham and Women's Hospital
$2,782,002

Key Dates

July 2021
July 2028
2021

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Last updated: March 16, 2022