Novo Nordisk’s Ozempic improves walking distance in PAD patients with Type 2 diabetes

DENMARK—Danish pharmaceutical giant Novo Nordisk has unveiled comprehensive results from the STRIDE trial, a Phase 3b study investigating the effects of once-weekly Ozempic (semaglutide 1.0 mg) injections on adults with type 2 diabetes and peripheral artery disease (PAD).

The findings were unveiled at the American College of Cardiology’s Annual Scientific Session and Expo in Chicago and simultaneously published in The Lancet.

This significant research highlights the potential of semaglutide to address a critical unmet need in managing PAD, a condition that severely affects millions worldwide.

Peripheral artery disease is a serious type of atherosclerotic cardiovascular disease that is often underdiagnosed and affects about 230 million people worldwide.

Notably, nearly one in three individuals with PAD also have type 2 diabetes, which exacerbates the condition by affecting small blood vessels and limiting the effectiveness of treatments like revascularization procedures.

The STRIDE trial aimed to assess whether semaglutide could improve functional outcomes in this challenging patient population.

The double-blind, randomized, placebo-controlled trial included 792 adults with type 2 diabetes and symptomatic peripheral artery disease (PAD).

 The results were striking: semaglutide 1.0 mg demonstrated a 13% superior improvement in maximum walking distance compared to the placebo at week 52.

This improvement translated to a mean treatment difference of 39.9 meters on a steep incline, a clinically meaningful outcome that could significantly enhance patients’ quality of life.

 Moreover, semaglutide outperformed the placebo in all secondary outcomes, including pain-free walking distance and health-related quality of life as measured by the Vascular Quality of Life Questionnaire-6 at week 52.

Marc P. Bonaca, MD, Director of Vascular Research at the University of Colorado School of Medicine and lead investigator of the STRIDE trial, emphasized the significance of these findings.

 He noted that semaglutide is the first medication in over two decades to show meaningful improvements in functional capacity and quality of life for individuals with both PAD and type 2 diabetes.

This breakthrough could address a critical gap in treatment options for this patient group, where even simple tasks like walking can become challenging due to severe symptoms and physical limitations.

The safety profile of semaglutide in the STRIDE trial was consistent with its established safety and tolerability.

Serious adverse events (SAEs) were reported in fewer participants in the semaglutide group than in the placebo group, with 74 and 78 participants experiencing SAEs, respectively.

Notably, SAEs leading to death occurred in 3 participants in the semaglutide arm and 8 in the placebo arm, but none of these fatalities were attributed to the treatment itself.

Encouraged by these results, Novo Nordisk has submitted a label extension application for Ozempic to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), with a decision expected in 2025.

 This move reflects Novo Nordisk’s shifting focus from diabetes and obesity to a broader spectrum of metabolic and cardiovascular health.

As noted by Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, this data highlights the comprehensive health benefits of semaglutide, making it a strong option for healthcare professionals focused on metabolic and cardiovascular health.

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