1. Dasiglucagon, a next‐generation ready‐to‐use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial
- Author
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Thomas Danne, Jenine Y Stone, Timothy S. Bailey, Linda A. DiMeglio, Thekla von dem Berge, Klemen Dovc, Ramin Tehranchi, Tadej Battelino, Anita E. Melgaard, and Stephanie Woerner
- Subjects
Blood Glucose ,Male ,Clinical Care and Technology ,Adolescent ,Nausea ,type 1 diabetes ,Endocrinology, Diabetes and Metabolism ,Injections, Subcutaneous ,Slovenia ,030209 endocrinology & metabolism ,Hypoglycemia ,Placebo ,Glucagon ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,law ,Diabetes mellitus ,Germany ,Internal Medicine ,medicine ,Clinical endpoint ,double‐blind trial ,Humans ,Insulin ,030212 general & internal medicine ,Child ,Type 1 diabetes ,business.industry ,hypoglycemic agent ,Patient Acuity ,medicine.disease ,United States ,Diabetes Mellitus, Type 1 ,Treatment Outcome ,Anesthesia ,Pediatrics, Perinatology and Child Health ,Female ,medicine.symptom ,business - Abstract
Background Dasiglucagon, a next‐generation, ready‐to‐use aqueous glucagon analog formulation, has been developed to treat severe hypoglycemia in individuals with diabetes. Objective The aim of this trial was to evaluate the safety and efficacy of dasiglucagon in pediatric individuals with type 1 diabetes (T1DM). Participants were children and adolescents (6–17 years) with T1DM. Methods In this randomized double‐blind trial, 42 participants were randomly allocated (2:1:1) to a single subcutaneous (SC) injection of dasiglucagon (0.6 mg), placebo, or reconstituted glucagon (GlucaGen; dosed per label) during insulin‐induced hypoglycemia. The primary endpoint was time to plasma glucose (PG) recovery (first PG increase ≥20 mg/dL after treatment initiation without rescue intravenous glucose). The primary comparison was dasiglucagon vs. placebo; glucagon acted as a reference. Results The median time (95% confidence interval) to PG recovery following SC injection was 10 min (8–12) for dasiglucagon vs. 30 min (20 to –) for placebo (P
- Published
- 2021