PISA — Findings from the SURPASS-EARLY trial were presented at the American Diabetes Association annual meeting. The study examined the effects of tirzepatide (Mounjaro) in people newly diagnosed with type 2 diabetes, with investigators suggesting it may support a more comprehensive early treatment approach.

Stefano Del Prato, an investigator at the University of Pisa in Italy, said the trial’s results align with recent guidelines from the American Diabetes Association and European Association for the Study of Diabetes. "Tirzepatide [Mounjaro] in this specific case provides us a better opportunity to really try to meet the recommendation from guidelines or consensus like the most recent or the last version of the ADA/EASD consensus where it was recommended that at the time of the diagnosis in people with type 2 diabetes, we should really try and strive to achieve good glycemic control, still the main factor driving the risk of microvascular complication; to focus more on body weight, because early [loss] in initial body weight can provide more metabolic effect and actually increase the potential for diabetes remission; focus from the very beginning on cardiovascular risk factors -- lipids, blood pressure, hypertension, and inflammation and so on and so forth; and of course to consider whatever is needed to do a specific intervention because people may already have an organ damage like a prior cardiovascular event or an initial chronic kidney disease," he said.

Del Prato added that SURPASS-EARLY points to a shift in how type 2 diabetes might be managed from diagnosis. "What I think SURPASS-EARLY suggests is a potential to have a more holistic comprehensive treatment from the very beginning of the disease with the expectation, of course, that would require specific evidence to be gathered to bend what has been seen so far as the natural history of type 2 diabetes," he said. He noted that the natural history of diabetes has typically been viewed as an unavoidable progression requiring treatment intensification over time.

The trial’s approach builds on prior research, including the U.K. Prospective Diabetes Study and the Steno-2 trial, which demonstrated benefits from early, multifactorial intervention targeting glycemic control alongside blood pressure and lipid profiles. Del Prato said SURPASS-EARLY offers a simplified system that simultaneously addresses multiple treatment targets. "These results shed initial light on potential for really being more comprehensive from the very beginning and really hit multiple targets with a more simplified system approach," he said.

Regarding safety, Del Prato reported that side effects were consistent with those expected from GLP-1 receptor agonists. "Safety was the typical one that has been reported for GLP-1 receptor agonists," he said. He noted that gastrointestinal side effects occurred but were similar in both the treatment and control groups, with 85% of control group participants also receiving a GLP-1 receptor agonist. Dropout rates did not differ significantly between groups, and tolerability aligned with typical GLP-1 receptor agonist treatment.

Del Prato concluded that the findings support sustained use of this early-intervention strategy in patients with newly diagnosed type 2 diabetes. "Which also supports the potential implementation and persistent use of this approach in people with early disease and with type 2 diabetes," he said.