At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 31 enrolled
Drug / intervention
Glucagondrug
Likely dose
Glucagon 1.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes
In Brief
A Phase 3 clinical trial evaluating Glucagon for Diabetes Mellitus, Type 1. Completed, enrolled 31 participants across 7 sites.
Detailed Summary
This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes. Subjects will be administered insulin to induce a low normal glycemic state and will then receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center (CRC) or comparable setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsThe Emmes Company, LLC
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartMar 2017
Primary CompletionSep 2017
Study CompletionSep 2017
TodayJul 2026
First PostedMar 27, 2017
Enrollment StartMar 27, 2017
Primary CompletionSep 7, 2017
Study CompletionSep 27, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.3 years ago
Interventions
Glucagondrug
0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector