Xeris Pharmaceuticals, Inc. announced it has 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).
Glucagon is a 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.
“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,” Dr. Ronnie Aronson, chief medical officer of LMC Diabetes & Endocrinology, Toronto, Canada said in a statement. “Unfortunately, today there are no approved therapies to prevent EIH.”
Aronson says this research will help researchers understand the potential for ready-to-use glucagon to offer real-world benefit in reducing or preventing these challenging events during exercise. Aronson is the principal investigator on the EIH trial.
The 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.
Source:
- Xeris Pharmaceuticals Doses First Patient in Phase 2 Trial Evaluating Its Ready-to-Use Glucagon to Address Exercise-Induced Hypoglycemia. (2019, March 14) BusinessWire. Retrieved: https://www.businesswire.com/news/home/20190314005698/en