Xeris Doses First Patient in Phase 2 Trial Evaluating Its Ready-to-Use Glucagon to Address Exercise-Induced Hypoglycemia
Xeris Pharmaceuticals announced that it has now begun dosing patients in a Phase 2 trial with its ready-to-use, room-temperature stable liquid glucagon in patients with Type 1 diabetes who experience episodes of exercise-induced hypoglycemia (EIH).
“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,” said Dr. Ronnie Aronson, MD, FRCPC, FACE, endocrinologist and chief medical officer of LMC Diabetes & Endocrinology, Toronto, Canada. Dr. Aronson is the principal investigator on the EIH trial.
This Phase 2 study will evaluate Xeris’ ready-to-use glucagon as a pre-treatment to prevent exercise-induced hypoglycemia in 48 patients with Type 1 diabetes who receive daily insulin treatment via a subcutaneous infusion pump. In the two-period cross-over comparison study, patients will receive ready-to-use glucagon or placebo before at least 45 minutes of moderate or high intensity aerobic exercise in a clinical research center. Additional data will then be collected via a parallel comparison in an outpatient setting with a similar regimen involving at least 30 minutes of aerobic exercise performed by subjects 3-5 times per week for 12 weeks.
Xeris expects top-line results from the study in the second half of 2019. For more information, visit clinicaltrials.gov, identifier NCT03841526.