Phase III data support dasiglucagon use for severe hypoglycemia
medwireNews: Dasiglucagon has potential as a fast, effective treatment for severe hypoglycemia in patients with type 1 diabetes, show phase III study data presented at the 79th ADA Scientific Sessions in San Francisco, California, USA.
Thomas Pieber, from the Medical University of Graz in Austria, reported that the median time to plasma glucose recovery following a fall of 20 mg/dL due to induced hypoglycemia was 10 minutes among the 82 patients who received dasiglucagon 0.6 mg via a novel ready-to-use auto-injector.
This was significantly greater than the 40-minute recovery time observed among the 43 patients randomly assigned to placebo, and similar to the 12 minutes taken to recover following treatment with the reference drug GlucaGen®.
Furthermore, 65% of patients receiving dasiglucagon recovered within 10 minutes, versus none and 49%, with placebo and GlucaGen®, respectively.
And all but one of the patients (99%) in the dasiglucagon group had recovered after 15 minutes, compared with 2% of those in the placebo group and 95% of those in the GlucaGen® group.
Pieber noted that the single patient in the dasiglucagon group who did not recover within 15 minutes was just 1 mg/dL below the threshold for recovery (a plasma glucose increase of at least 20 mg/dL).
He also told delegates that dasiglucagon use was not associated with any unexpected adverse events (AEs). Just over half (55%) of study participants reported nausea and just under a quarter (23%) experienced vomiting, which was similar to the rates among patients receiving GlucaGen® (53% and 19%, respectively). There were no severe AEs in either group.
Pieber concluded that the results of this “pivotal trial” suggest that “dasiglucagon is a promising candidate for the treatment of severe hypoglycemia.”
He added that the first experiments incorporating dasiglucagon into an artificial pancreas system are underway.
By Laura Cowen
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