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

NCT03841526 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-22

Study results available
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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.

Conditions

Interventions

DRUG

Glucagon RTU Injection With Insulin Pump Reduction

0.15 mg injection with 50% pump reduction

OTHER

Vehicle for Glucagon RTU Injection With Insulin Pump Reduction

vehicle injection with 50% pump reduction

DRUG

Glugaon RTU Injection Without Insulin Pump Reduction

0.15 mg injection without pump reduction

Sponsors & Collaborators

  • Xeris Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Khaled Junaidi, MD · Xeris Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2020-04-02
Completion
2020-04-02
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841526 on ClinicalTrials.gov