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Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetesHeller, 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, seriousPublish date - 2023Language - englishCOBISS.SI-ID - 148383747
Author
Heller, Simon |
Battelino, Tadej |
Bailey, Timothy S. |
Pieber, Thomas R |
Hövelmann, Ulrike |
Plum-Mörschel, Leona |
Melgaard, Anita E. |
Aronson, Ronnie |
DiMeglio, Linda A. |
Johansen, Thue |
Danne, Thomas, 1959-
Topics
glukagon |
nadzor glikemije |
diabetes tipa 1 |
glucagon |
glycaemic control |
type 1 diabetes
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Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Heller, Simon | ![]() |
Battelino, Tadej | 13023 |
Bailey, Timothy S. | ![]() |
Pieber, Thomas R | ![]() |
Hövelmann, Ulrike | ![]() |
Plum-Mörschel, Leona | ![]() |
Melgaard, Anita E. | ![]() |
Aronson, Ronnie | ![]() |
DiMeglio, Linda A. | ![]() |
Johansen, Thue | ![]() |
Danne, Thomas, 1959- | ![]() |
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