At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
G-Pen(TM) 1 mg +2 moredrug
Likely dose
G-Pen(TM) 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.
A RANDOMIZED, PHASE 2, DOUBLE-BLIND, 3-WAY CROSSOVER STUDY WITH G-PEN™ (GLUCAGON INJECTION) TO EVALUATE SAFETY, TOLERABILITY AND COMPARATIVE PHARMACOKINETICS AND PHARMACODYNAMICS TO LILLY GLUCAGON™ (GLUCAGON FOR INJECTION [rDNA ORIGIN]) IN HEALTHY VOLUNTEERS
In Brief
A Phase 2 clinical trial evaluating G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg, and 1 other intervention for Hypoglycemia. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoglycemia
CountriesUnited States
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedOct 2013
Primary CompletionFeb 2014
TodayJul 2026
First PostedOct 30, 2013
Enrollment StartOct 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.7 years ago
Interventions
G-Pen(TM) 1 mgdrug
Lilly Glucagon(TM) 1 mgdrug
G-Pen(TM) 0.5 mgdrug