Treatment with human glucagon analog formulation dasiglucagon led to rapid restoration of plasma glucose levels in children and adolescents with type 1 diabetes mellitus who experienced insulin-induced hypoglycemia, according to the results of a study published in Pediatric Diabetes.
A total of 42 children and adolescents (age range, 7-17 years) from Germany, Slovenia, and the United States were randomly assigned in a 2:1:1 ratio in this phase 3 study to receive either a single subcutaneous injection of dasiglucagon 0.6 mg (n=21), placebo (n=11), or a reference treatment consisting of reconstituted glucagon (n=10) during an insulin-induced hypoglycemia event. The trial protocol described randomization as stratified by age group and injection site.
Researchers examined the time to plasma glucose recovery, defined as the first increase of plasma glucose ≥20 mg/dL following treatment without the need for rescue intravenous glucose.
Patients who received dasiglucagon had a significantly shorter median time to plasma glucose recovery (10 minutes; 95% CI, 8-12) compared with patients who received placebo (30 minutes; 95% CI, 20-not estimable; P <.001). For the glucagon group, the median time to plasma glucose recovery was 10 minutes (95% CI, 8-12), but this did not include the amount of time spent reconstituting the lyophilized powder.
All participants in the dasiglucagon and glucagon arms of the study experienced plasma glucose recovery within 20 minutes of dosing, but only 18% of patients in the placebo group achieved recovery. A significantly greater proportion of participants in the dasiglucagon arm experienced glucose recovery within 10, 15, 20, and 30 minutes of dosing compared with the placebo group (P <.01 at each timepoint).
There were no serious or severe adverse events during the trial. Nausea and vomiting, adverse events expected with glucagon, were frequently reported with dasiglucagon. Most episodes of nausea began within 1.5 to 3 hours following dosing, and most of these episodes lasted less than 2 hours.
A limitation of this trial was that it was conducted in a highly controlled investigational inpatient setting, which the investigators note “may not fully reflect conditions in the real world.”
The researchers concluded that these findings support “the use of a common subcutaneous dose of dasiglucagon (0.6 mg) to treat severe hypoglycemia in pediatric…and adult individuals with diabetes.”
Disclosure: Some study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of disclosures.
Battelino T, Tehranchi R, Bailey T, et al. Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: results of a phase 3, randomized controlled trial. Pediatr Diabetes. Published online May 2, 2021. doi:10.1111/pedi.13220