drugset / Trial / NCT03841526

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

NCT03841526

Phase 2 Completed 48 enrolled Xeris Pharmaceuticals
RandomizedSequentialQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Glucagon Peptide 0.15 mg Subcutaneous

Indications