At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Randomized Placebo-Controlled Double-Blind Parallel Study to Evaluate Glucagon RTU (Glucagon Injection) Compared to Standard of Care for Prevention of Exercise-Induced Hypoglycemia During Regular Aerobic Exercise in Adults With T1D
In Brief
A Phase 2 clinical trial evaluating Glucagon RTU Injection With Insulin Pump Reduction, Vehicle for Glucagon RTU Injection With Insulin Pump Reduction, and 1 other intervention for Hypoglycemia. Completed, enrolled 48 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
0.15 mg injection with 50% pump reduction
vehicle injection with 50% pump reduction
0.15 mg injection without pump reduction