Xeris Pharmaceuticals, a specialty pharmaceutical company based in Chicago, has announced the commencement of dosing in its phase 2 clinical trial. The trial aims to evaluate its ready-to-use, room temperature-stable glucagon in patients with Type 1 diabetes who suffer from exercise-induced hypoglycemia (EIH). This is a critical step for the company as it looks to offer a novel solution to a significant challenge for individuals with diabetes who face hypoglycemic episodes during physical activity.

Exercise-induced hypoglycemia is a common complication for individuals with Type 1 diabetes, especially those on insulin therapy. The condition can pose significant barriers to engaging in regular physical activity, which is crucial for overall health and well-being. Currently, there are no approved therapies to prevent EIH, making this research vital for improving treatment options and supporting the adoption of regular exercise in this patient group.

The clinical trial will assess the effectiveness of Xeris Pharmaceuticals’ glucagon as a pre-treatment for preventing hypoglycemia in patients with Type 1 diabetes. A total of 48 patients will be enrolled in the study. These patients will receive daily insulin treatment via subcutaneous infusion pumps, with the trial exploring how ready-to-use glucagon or a placebo can help prevent EIH during exercise.

Participants will undergo at least 45 minutes of moderate or high-intensity aerobic exercise at a clinical research center as part of a two-period, cross-over comparison study. In addition to this controlled setting, further data will be collected through a parallel comparison in an outpatient setting. This will involve more than 30 minutes of aerobic exercise performed 3 to 5 times per week for a period of 12 weeks, providing a more real-world context for evaluating the glucagon treatment’s potential.

The study’s primary goal is to determine the benefit of Xeris Pharmaceuticals’ glucagon in preventing hypoglycemia during exercise. With its novel formulation, Xeris’ glucagon could offer a much-needed solution for people with diabetes who experience frequent, unpredictable drops in blood sugar levels during physical activity.

Dr. Ronnie Aronson, the principal investigator of the EIH trial, emphasized the significance of this research, noting the lack of approved treatments for exercise-induced hypoglycemia. He stated, “Many individuals with diabetes treated with insulin experience EIH and the complexity of managing it is a major barrier to the adoption of regular physical activity. And unfortunately, today there are no approved therapies to prevent EIH. This research will help us understand the potential for ready-to-use glucagon to offer real-world benefit in reducing or preventing these challenging events during exercise.”

Xeris Pharmaceuticals is expecting to release the top-line results from this phase 2 trial in the second half of 2019. The outcomes of this trial could be pivotal for advancing the company’s ready-to-use glucagon as a therapeutic option for Type 1 diabetes patients who struggle with exercise-induced hypoglycemia, potentially opening new doors for better management of the disease.

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