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  • Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes
    Heller, Simon ...
    Aims: To perform an integrated analysis of the safety and efficacy of dasiglucagon, a glucagon analogue available in a ready-to-use aqueous formulation, to treat severe hypoglycaemia (SH) in type 1 ... diabetes (T1D). Materials and methods: An integrated analysis of dasiglucagon safety was conducted on data from two placebo-controlled trials (placebo-controlled pool) and two placebo-controlled and four non-placebo-controlled trials (broad pool) in adults with T1D. An integrated analysis of dasiglucagon efficacy was conducted of pooled data and within demographic subgroups from the two placebo-controlled and two non-placebo-controlled trials in adults with T1D. Results: Dasiglucagon had a similar safety and tolerability profile to that of reconstituted glucagon. In the placebo-controlled datasets, no serious adverse events (AEs), AEs leading to withdrawal from the trial, or deaths were reported. The most common causally related AEs were nausea (56.5%) and vomiting (24.6%). The broad pool safety analysis showed similar results. Dasiglucagon efficacy in time to plasma glucose recovery from insulin-induced SH was similar to that of reconstituted glucagon (median 10.0 and 12.0 minutes, respectively) and superior to placebo (median 40.0 minutes; P < 0.0001). The median recovery time was consistent across all placebo-controlled trial subgroups. Conclusions: Dasiglucagon was well tolerated and effective as a rapid rescue agent for insulin-induced SH in people with T1D.
    Source: Diabetes, obesity and metabolism. - ISSN 1462-8902 (Vol. 25, iss. 5, May 2023, str. 1351-1360)
    Type of material - article, component part ; adult, serious
    Publish date - 2023
    Language - english
    COBISS.SI-ID - 148383747

    Link(s):

    https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.14987
    DOI

source: Diabetes, obesity and metabolism. - ISSN 1462-8902 (Vol. 25, iss. 5, May 2023, str. 1351-1360)
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