“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.
Glucagon is a metabolic hormone secreted by the pancreas that raises blood glucose levels by causing the liver to rapidly convert glycogen (the stored form of glucose) into glucose, which is then released into the bloodstream.
Glucagon and insulin are two critical hormones in a glycemic control system that keep blood glucose at the right level in healthy individuals.
In people with diabetes who are dependent on insulin, this control system is disrupted and insulin must be injected to avoid high levels of blood glucose (hyperglycemia). The opposite effect, or low blood glucose (hypoglycemia), is also prevalent in this population due to dysregulated glucagon secretion.
Severe hypoglycemia is a serious condition and can lead to seizures, coma, potential brain injury and, if untreated, death.
Source: Company Press Release