Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes
| Autor: | Bruce Buckingham, Jennifer Sherr, Steven J. Prestrelski, Valentina Conoscenti |
|---|---|
| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Pediatric Diabetes. 23:754-762 |
| ISSN: | 1399-5448 1399-543X |
| DOI: | 10.1111/pedi.13360 |
| Popis: | Prompt and reliable management of hypoglycemia in youth with diabetes is important to prevent serious medical complications.To determine efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of a ready-to-use, liquid stable glucagon formulation administered subcutaneously via an autoinjector pen to youth with type 1 diabetes (T1D).After plasma glucose concentration was 80 mg/dL ( 4.4 mmol/L) after insulin, participants aged 2 to 12 years with T1D were administered 0.5 mg of glucagon; participants aged 12 to 18 years instead received 1 mg of glucagon. Then, adolescents were challenged with 0.5 mg after a 7- to 28-day washout period. Primary endpoint was mean plasma glucose concentration at 30 min after glucagon.Plasma glucose concentrations significantly (p 0.001) increased from baseline to 30 min after glucagon, with mean change in plasma glucose concentration between baseline and 30 min for each age cohort as follows: 2 to 6 years (n = 7; 81.4 mg/dL [4.5 mmol/L]); 6 to 12 years (13; 84.2 mg/dL [4.7 mmol/L]); 12 to 18 years (11; dose, 1 mg; 54.0 mg/dL [3.0 mmol/L]); and 12 to 18 years (11; 0.5 mg; 52.4 mg/dL [2.9 mmol/L]). Among age cohorts, no clinically relevant differences were observed for PD and PK parameters. Common adverse events were nausea, vomiting, and hypoglycemia.Age-appropriate dosing of this glucagon formulation was effective at 30 min in reversing plasma glucose concentrations from 80 mg/dL in youth with T1D. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|