期刊
DIABETES OBESITY & METABOLISM
卷 23, 期 10, 页码 2329-2335出版社
WILEY
DOI: 10.1111/dom.14475
关键词
Dasiglucagon; double-blind trial; glucagon; hypoglycaemia; type 1 diabetes
资金
- Zealand Pharma
Dasiglucagon administered via an autoinjector device provided rapid reversal of hypoglycaemia in adults with type 1 diabetes, with no serious adverse events reported. The aqueous formulation of dasiglucagon in a ready-to-use autoinjector device may offer a reliable treatment option for severe hypoglycaemia.
Aim To confirm the efficacy and safety of dasiglucagon when administered via an autoinjector device. Materials and Methods In this double-blind trial, 45 participants with type 1 diabetes were randomized 3:1 to receive a single subcutaneous dose of dasiglucagon 0.6 mg or placebo following controlled induction of hypoglycaemia. The primary endpoint was time to plasma glucose recovery, defined as a plasma glucose increase of 20 mg/dL or higher from baseline without rescue intravenous glucose. Results Median (95% CI) observed time to recovery was 10.0 (8.0; 12.0) minutes for dasiglucagon and 35.0 (20.0; -) minutes for placebo (P < .001). Plasma glucose recovery was achieved within 15 minutes by 88% of participants receiving dasiglucagon versus none receiving placebo (P < .01). Site of injection (buttock or deltoid) was not shown to have any effect on time to recovery (P = .84). No serious adverse events occurred. As expected for glucagon treatment, nausea and vomiting were common adverse events in dasiglucagon-treated participants. Conclusions Dasiglucagon provided rapid reversal of hypoglycaemia in adults with type 1 diabetes. Dasiglucagon administration was well tolerated. The aqueous formulation of dasiglucagon in a ready-to-use autoinjector device that can be carried at room temperature may provide a reliable treatment for severe hypoglycaemia.
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