Denmark-based Zealand Pharma (Zealand) has begun its Phase IIa clinical trial of dasiglucagon in a dual-hormone artificial (or bionic) pancreas system from Beta Bionics for hypoglycaemia.
Dasiglucagon is an analogue of peptide hormone human glucagon, which is produced by alpha cells of the pancreas and released to prevent blood glucose levels dropping low, thereby ensuring a well-functioning metabolic system.
The multiple-dose version of dasiglucagon is aimed to be used in a dual-hormone artificial pancreas system to better manage hypoglycaemia and offer easier options to insulin treated diabetes patients for effective management of their disease.
A dual-hormone artificial (or bionic) pancreas system, designed to automatically deliver insulin and glucagon to people with type 1 diabetes, copies the function of a healthy pancreas.
The Phase IIa trial is the fourth Phase II trial initiated by Zealand this year that intends to determine the safety, efficacy and tolerability of dasiglucagon as part of the Beta Bionics dual-hormone artificial (bionic) pancreas system in adult patients with type 1 diabetes, compared to a recombinant market glucagon.
The company previously entered into collaboration with Beta Bionics, which is developing the dual-hormone artificial (bionic) pancreas system based on technology conceived at Boston University.
The trial's principal investigator Steven Russell said: “This Phase IIa study will test the effectiveness of the stable glucagon analogue dasiglucagon in the dual-hormone bionic pancreas, comparing it with the unstable glucagon formulation that we have used in all of our previous studies.
“Demonstrating the effectiveness of a stable glucagon formulation or analogue, such as dasiglucagon, is an essential step towards making a dual-hormone bionic pancreas available to patients."
The Phase IIa trials are expected to pave the way for longer clinical trials, with the multiple-dose version of dasiglucagon in the dual-hormone artificial pancreas system.
Results from both trials are expected in the first quarter of next year.