Two newer classes of type 2 diabetes medications have the potential to transform the way people manage the condition that currently impacts more than 32 million Americans. Recent studies have shown that sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) not only control blood sugar, but may also reduce risk of heart attack, stroke, hospitalization for heart failure, and death due to cardiovascular causes in those with established cardiovascular disease and those at high risk. These events are the most common cause of disability and death in patients with type 2 diabetes. The development of SGLT2i and GLP-1 RA medications represent a tremendous breakthrough. But questions remain. Which is better? And, perhaps even more intriguing, might these medicines work even better in combination?
PRECIDENTD (PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes) is a study combining the power of PCORnet, the National Patient-Centered Clinical Research Network, and patient insights to find out. The study, which is funded by the Patient-Centered Outcomes Research Institute, plans to recruit 9,000 adults with type 2 diabetes and with or at high risk for heart disease via eight PCORnet sites to be randomly assigned treatment with an SGLT2i, a GLP-1 RA, or both. These patients will be followed by the study team for an average of nearly four years to determine which medication approach is most effective at reducing major health events, such as heart attack, stroke, kidney problems, and death.
“Of the 32 million Americans living with type 2 diabetes, more than 20 million also have, or are at high risk for, heart disease,” said Brendan Everett, principal investigator for PRECIDENTD. “Two newer classes of drugs that effectively treat both conditions concurrently represent a huge advance in diabetes care that’s no less significant than the introduction of statins for heart health in 1991. But no study has compared the classes head-to-head to guide patients on which one is better, and in what circumstances. Those are the questions PRECIDENTD hopes to answer.”
Breaking the ‘curse of knowledge’ is key, says patient partner
The research team knows it can’t deliver answers on its own. Encouraging patients to participate in a randomized trial is always a challenge. To understand and overcome potential obstacles to participation, PRECIDENTD established a patient-centered advisory board comprised of people with diabetes to share their experience and serve as influencers for patients participating in the study.
One of those patient influencers, Ed Simeone, says reaching diabetes patients effectively comes down to breaking the “curse of knowledge,” or the assumption that everyone in the room shares your knowledge and perspective.
“When study materials are packed with technical jargon, they aren’t educational or motivating to the layperson,” said Ed. “We need to transcend that jargon and help patients understand that what sits before them is an opportunity to have a remarkable impact on diabetes care. No diabetes patient should suffer a stroke simply because the potential benefits of the new treatments available weren’t clear.”
Ed sits in regular Zoom calls along with five other patients, the study principal investigator, and medical professionals spanning endocrinology, cardiology and more, to explain what goals and health outcomes are important to the diabetes community. Together, the advisory board develops tactics to ensure the study team works with all stakeholders and enrolls participants from racial and ethnic groups with high diabetes prevalence, many of which have also historically been excluded from diabetes research. Patient partners were pivotal in designing PRECIDENTD’s endpoints and engagement materials; when the study concludes, they will play an important role in sharing results, too, ensuring that the findings are integrated into usual care and make sense to frontline providers and their patients.
“Other studies I’ve participated in took blood and moved on,” said Ed. “As an advisory board member, I see my advice come to life. They are thirsty for our perspective and bring a humility that, frankly, could serve all future research.”
The PRECIDENTD study is currently setting up contracts with enrolling sites through PCORnet. Results are expected in 2028, which will help patients, their families, and their healthcare providers decide which type of diabetes medication is best for their specific combination of medical conditions, preferences, and goals.
