Xeris Pharmaceuticals and OHSU Conducting Artificial Pancreas Clinical Trial Using Xeris’ Novel Ready-to-Use Liquid Glucagon
Patients enrolling in Phase 1 clinical trial using Xeris’ ready-to-use liquid glucagon formulation as part of a fully integrated, dual-hormone closed-loop system
Managing diabetes requires ongoing monitoring of blood glucose levels
and regular intervention with glucose and insulin – a burdensome process
for the over five million people on insulin in
Xeris’ ready-to-use liquid glucagon is room-temperature stable over extended periods of time, thereby enabling a dual-hormone artificial pancreas system to be possible. The ability to co-administer both insulin and stable liquid glucagon in one system may reduce the risk of hypoglycemia by mirroring the body’s normal glucose control, which is especially important during periods of exercise.
Supported by funding from JDRF, the leading global organization funding type 1 diabetes (T1D) research, OHSU is conducting a Phase 1 single-center, randomized, three-way, controlled, crossover clinical study to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with T1D before and after exercise.
“JDRF is excited to support OHSU’s research into ready-to-use liquid
The purpose of this study is to determine whether a dual hormone artificial pancreas using Xeris’ ready-to-use liquid glucagon with an exercise detection algorithm outperforms both single hormone artificial pancreas and a low glucose suspend algorithm. In addition to the dual hormone therapy, this integrated system includes a continuous glucose monitor (“CGM”), an infusion pump, and a control algorithm that actuates the pump based upon real time CGM data. Study results are expected in the first half of 2019.
“The goal in researching our liquid stable glucagon formulation as part
of a dual-hormone closed-loop mated system is to overcome the
limitations of current dry-powder glucagon formulations in automated
pump systems to manage diabetes; this trial will help us better
understand the potential application of our ready-to-use glucagon
For further information on the clinical trial see ClinicalTrials.gov Identifier: NCT03424044.
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
Xeris is a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations. The Company’s proprietary XeriSol™ and XeriJect™ formulation technologies are being evaluated for the subcutaneous (SC) and intramuscular (IM) delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, proteins, antibodies, and small molecules using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. Xeris' platforms have the potential to offer distinct advantages over existing formulations of marketed and development-stage products. In particular, XeriSol™ and XeriJect™ have the potential to eliminate the need for reconstitution, enable long-term, room-temperature stability, significantly reduce injection volume, and eliminate the requirement for intravenous (IV) infusion. These attributes may lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system. Further information about Xeris can be found at www.xerispharma.com.
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