A Multi-Centre, Randomized, Controlled, Single-Blind, 2-Way Crossover Study To Compare 2 Glucagon Formulations For Induced Hypoglycemia Rescue In Adults With Type 1 Diabetes Mellitus (T1DM)

This study was a multi-center, randomized, controlled, single-blind, two-way crossover, inpatient trial designed to assess non-inferiority in subjects with Type 1 Diabetes Mellitus (T1DM). The primary objective was to evaluate the efficacy of a new glucagon injectable device in comparison to an established treatment for managing insulin-induced hypoglycemia. A total of up to 85 male and female participants with T1DM were enrolled and randomized to receive either the investigational product or the comparator in a crossover design, with each participant experiencing both treatments over two study periods.

One of the participating sites, Altasciences in Montreal, played a crucial role in this trial. Despite strict inclusion and exclusion criteria, as well as the requirement for participants to demonstrate stable glucose control, the Montreal site successfully recruited and randomized eight patients within just two weeks. This rapid recruitment is particularly notable given the complexity of the study design and the specific requirements for patient eligibility. The site’s ability to meet these challenges highlights its strong clinical capabilities and commitment to advancing diabetes research.