At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 80 enrolled
Drug / intervention
G-Pen (glucagon injection) +1 moredrug
Likely dose
G-Pen (glucagon injection) 1 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.
G-Pen (Glucagon Injection) Compared to Lilly Glucagon (Glucagon for Injection [RDNA Origin]) for Induced Hypoglycemia Rescue in Adult Patients With T1DM: A Phase 3, Multi-center, Randomized, Blinded, 2-Way Crossover Study to Evaluate Efficacy and Safety
In Brief
A Phase 3 clinical trial evaluating G-Pen (glucagon injection) and Lilly Glucagon (glucagon injection [rDNA origin]) for Hypoglycemia and Diabetes Mellitus, Type 1. Completed, enrolled 80 participants across 7 sites in 2 countries.
Detailed Summary
This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection \[rDNA origin\]) for hypoglycemia rescue of adult patients with type 1 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoglycemia, Diabetes Mellitus, Type 1
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartMar 2017
Primary CompletionAug 2017
Study CompletionSep 2017
TodayJul 2026
First PostedJan 14, 2016
Enrollment StartMar 15, 2017
Primary CompletionAug 14, 2017
Study CompletionSep 25, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.5 years ago
Interventions
G-Pen (glucagon injection)drug
1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
Lilly Glucagon (glucagon injection [rDNA origin])drug
1 mg of Lilly glucagon reconstituted from lyophilized powder