Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D

Summary

This study is a randomized, placebo-controlled, double-blind, 2-treatment, 2-period, crossover comparison in a clinical research center (CRC) setting, followed by a randomized, placebo-controlled, double-blinded, 2-arm parallel comparison with a third open-label arm in an outpatient setting. The purpose of the study is to evaluate the preliminary efficacy and safety of Glucagon Ready-to-Use \[RTU\] to prevent exercise-induced hypoglycemia (EIH) in adults with Type 1 diabetes mellitus (T1D), who perform regular, moderate-to-high intensity aerobic exercise.

Timeline

Start

2019-08-22

Primary completion

2020-04-02

Completion

2020-04-02

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “Phase 2 Exercise-Induced Hypoglycemia (EIH) study show that a mini dose of RTU glucagon was adequate to maintain normal blood glucose levels” xerispharma.com ↗

Publications

• Results Aronson R, Riddell MC, Conoscenti V, Junaidi MK. Effect of Mini-Dose Ready-to-Use Liquid Glucagon on Preventing Exercise-Associated Hypoglycemia in Adults With Type 1 Diabetes. Diabetes Care. 2023 Apr 1;46(4):765-772. doi: 10.2337/dc22-1145.

Drugs

Indications