The Phase 3, multi-centre, randomised controlled, non-inferiority study was conducted among 132 adults with type 1 diabetes to evaluate the Xeris RTU glucagon auto-injector as a treatment for severe hypoglycemic events as compared with Novo Nordisk's GlucaGen HypoKit.
The results demonstrated comparable efficacy between the two groups for achieving a plasma glucose of >70 mg/dl or ≥20 mg/dl increase in plasma glucose concentration within 30 minutes of glucagon administration.
This study also found that time to resolution of hypoglycemia symptoms as well as time to resolution of the overall feeling of hypoglycemia was comparable between Xeris RTU glucagon and the marketed emergency kit.
Overall, no safety or tolerability concerns were noted. (EudraCT Number 2018-002661-19, NCT03738865)
A New Drug Application for the investigational product, to be branded as the Gvoke HypoPen in the US, is currently under review with the US Food and Drug Administration, with a decision expected September 10, 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.
Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association, glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose
vTv Therapeutics secures USD51m private placement for cadisegliatin Phase 3 study
AbbVie names new chief executive officer
SkinBioTherapeutics expands foot care products in AMEA with Dermatonics partnership
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Insulet's Omnipod 5 integration with Abbott FreeStyle Libre 2 Plus Sensor secures CE Mark approval
Kyowa Kirin enrols first subject in phase two tivozanib eye drops (KHK4951) clinical trial
China accepts GSK's Shingrix application for at-risk adults
Novo Nordisk to boost manufacturing capacity with acquisition of three fill-finish sites
Breye Therapeutics commences phase 1b/2a danegaptide clinical trial
DexCom Inc breaks ground on new manufacturing facility in Ireland
VibroSense Dynamics AB secures provisional patent for chemotherapy-induced nerve damage prediction
Innovent Biologics signs collaboration agreement with Sanegene Bio USA
Japan approves GSK's filing for Arexvy vaccination for at-risk adults