OBJECTIVE To evaluate the efficacy
and safety of dasiglucagon – a ready-to-use, next-generation glucagon analog in
aqueous formulation for subcutaneous dosing – for treatment of severe
hypoglycemia in adults with type 1 diabetes.
<p>RESEARCH DESIGN AND METHODS This
randomized, double-blind trial included 170 adult participants with type 1
diabetes, each randomized to receive a single subcutaneous dose of dasiglucagon
0.6 mg, placebo, or reconstituted glucagon 1 mg (2:1:1 randomization) during
controlled insulin-induced hypoglycemia. The primary endpoint was time to
plasma glucose recovery, defined as an increase of ≥20 mg/dL from baseline
without rescue intravenous glucose. The primary comparison was dasiglucagon
versus placebo; reconstituted lyophilized glucagon was included as reference.</p>
<p>RESULTS Median (95% CI) time to
recovery was 10 (10, 10) minutes for dasiglucagon compared to 40 (30, 40)
minutes for placebo (<i>P</i><0.001); the corresponding result for
reconstituted glucagon was 12 (10, 12) minutes. In the dasiglucagon group,
plasma glucose recovery was achieved within 15 minutes in all but one
participant (99%), superior to placebo (2%; <i>P</i><0.001) and similar to
glucagon (95%). Similar outcomes were observed for the other investigated time
points at 10, 20 and 30 minutes after dosing. The most frequent side effects
were nausea and vomiting, as expected for glucagon treatment.</p>
<p>CONCLUSIONS Dasiglucagon provided rapid
and effective reversal of hypoglycemia in adults with type 1 diabetes, with
safety and tolerability similar to that reported for reconstituted glucagon
injection. The ready-to-use, aqueous formulation of dasiglucagon offers the
potential to provide a rapid and reliable treatment for severe hypoglycemia.</p>
Dasiglucagon: A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia Results of Phase 3 Randomized Double-Blind Clinical Trial
