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
| العنوان: | 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 |
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| المؤلفون: | Thomas Danne, Jenine Y Stone, Timothy S. Bailey, Linda A. DiMeglio, Thekla von dem Berge, Klemen Dovc, Ramin Tehranchi, Tadej Battelino, Anita E. Melgaard, Stephanie Woerner |
| المصدر: | Pediatric Diabetes |
| بيانات النشر: | John Wiley & Sons A/S, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | 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 |
| الوصف: | 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 |
| اللغة: | English |
| تدمد: | 1399-5448 1399-543X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::84728d96071a01fac1a7fc0e2fa2cd48Test http://europepmc.org/articles/PMC8361970Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....84728d96071a01fac1a7fc0e2fa2cd48 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 13995448 1399543X |
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