Immunogenicity of the Novel Glucagon Analogue Dasiglucagon: Results of a Dedicated Immunogenicity Trial in Type 1 Diabetes

• Main Authors: Ajala, O. (Author), Dahl, D. (Author), Hansen, L.E (Author), Pieber, T.R (Author), Steen, O. (Author), Tehranchi, R. (Author)
• Format: Article
• Language: English
• Published: Mary Ann Liebert Inc. 2021
• Subjects: adult; antibody screening; Article; Blood Glucose; blood glucose monitoring; body mass; controlled study; cross reaction; dasiglucagon; Dasiglucagon; Diabetes Mellitus, Type 1; direct ELISA; disease duration; double blind procedure; Double-Blind Method; drug antibody; drug safety; enzyme linked immunosorbent assay; female; glucagon; Glucagon; glucose; glucose blood level; hemoglobin A1c; human; Humans; hypoglycemia; Hypoglycemia; immunogenicity; Immunogenicity; immunoglobulin G antibody; immunoglobulin M antibody; insulin dependent diabetes mellitus; insulin derivative; insulin infusion; insulin treatment; long acting insulin; major clinical study; male; multicenter study; nausea and vomiting; neutralization test; neutralizing antibody; randomized controlled trial; Randomized trial; recombinant glucagon; short acting insulin; Type 1 diabetes
• Online Access: View Fulltext in Publisher

 Dasiglucagon is a next-generation glucagon analogue that is stable in aqueous formulation. This dedicated immunogenicity trial to support use as rescue treatment for severe hypoglycemia was conducted to evaluate the immunogenicity of repeated subcutaneous doses of dasiglucagon in subjects with type 1 diabetes. A total of 112 subjects were randomized 1:1 to receive three subcutaneous weekly doses of either 0.6 mg dasiglucagon or 1.0 mg recombinant glucagon (GlucaGen®) according to a double-blind parallel-group trial design. Subjects were followed for 15 weeks, with a multitiered testing approach planned for assessment of antidrug antibody (ADA) formation. For the primary immunogenicity endpoint, the overall ADA incidence was zero, as no subject demonstrated any treatment-induced or treatment-boosted ADA response at any time point in this trial involving three consecutive weekly doses of trial drug. No injection site reactions were reported for subjects receiving dasiglucagon. There were no unexpected safety findings for the trial. © Thomas R. Pieber, et al., 2021; Published by Mary Ann Liebert, Inc. 2021.