Clinical Trials

Date: 2017-06-01

Type of information: Initiation of the trial

phase: 1

Announcement: initiation of the trial

Company: Adocia (France)

Product: BioChaperone® Glucagon

Action mechanism:

• The BioChaperone proprietary technology enables the solubilization and stabilization of human glucagon at neutral pH. A liquid formulation of human glucagon may have utility as a ready to-inject treatment for severe hypoglycemia as well as in a dual hormone artificial pancreas (DHAP), i.e. a fully automated pump that would deliver both insulin and glucagon as a function of the person’s real-time glycaemia.
• Human glucagon is the only product approved as an emergency treatment for severe hypoglycemia. Currently available emergency kits consist of lyophilized human glucagon for reconstitution immediately prior to injection (two available brands: GlucaGen HypoKit, Novo Nordisk and Glucagon, Eli Lilly). The usability of these kits, however, is poor as demonstrated in several clinical studies, due to the numerous steps required for reconstitution and administration. Therefore, there is a strong medical need for a ready-to-use solution in an auto-injector to simplify the injection and ensure the administration of the appropriate dose in an emergency situation. Adocia’s aqueous formulation of human glucagon could address the medical need for a readyto-use product for rescue from severe hypoglycemia and unlock the use of human glucagon as a chronic treatment in a DHAP. Adocia’s formulation strategy builds on the established safety and efficacy data sets for human glucagon.

Disease: type 1 diabetes

Therapeutic area: Metabolic diseases

Country:

Trial details:

Latest news:

• • On June 1, 2017, Adocia announced the initiation of a Phase 1 study of BioChaperone® Glucagon, its aqueous formulation of human glucagon. This study aims to assess the safety and tolerability of BioChaperone Glucagon (BC Glucagon) as compared to commercially available human glucagon (lyophilized powder reconstituted immediately prior to injection, GlucaGen® HypoKit®, Novo Nordisk). The study will evaluate two different fixed doses, representative of two distinct potential applications, i.e. rescue from severe hypoglycemia and repeated frequent micro-bolus administration in a DHAP system.
• In this randomized, double-blind, comparator-controlled, three-period, cross-over study, 27 participants with type 1 diabetes will be randomly allocated to a sequence of three treatments: BC Glucagon formulation 1, BC Glucagon formulation 2 and GlucaGen HypoKit. Each agent will be administered at a fixed dose of 50 µg and 1 mg, as two single subcutaneous injections, on three separate dosing visits. 1 mg is the standard dose for severe hypoglycemia rescue and 50 µg is similar to the micro-boluses used in an artificial pancreas system.
• The main objective of this study is to assess the safety and tolerability of subcutaneous single fixed doses of both BC Glucagon formulations and of GlucaGen HypoKit in subjects with type 1 diabetes.
• Secondary objectives include the comparison of the pharmacokinetic and pharmacodynamic profiles of BC Glucagon to those of GlucaGen HypoKit at two different doses. Results are expected during Q4 2017.

Is general: Yes