At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Nasal Glucagon 1 mg +3 moredrug
Likely dose
Nasal Glucagon 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.
Phase II Study to Investigate the Safety and Efficacy of 2 Dose Levels of a Novel Glucagon Formulation Compared to Commercially Available Glucagon in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
In Brief
A Phase 2 clinical trial evaluating Nasal Glucagon 1 mg, Nasal Glucagon 2 mg, and 2 other interventions for Hypoglycemia. Completed, enrolled 18 participants across 1 site.
Detailed Summary
In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours. The main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoglycemia
CountriesCanada
CollaboratorsLocemia Solutions ULC
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
First PostedMar 2012
Primary CompletionJul 2012
TodayJul 2026
First PostedMar 16, 2012
Enrollment StartMar 1, 2012
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.3 years ago
Interventions
Nasal Glucagon 1 mgdrug
Nasal Glucagon 2 mgdrug
SC Glucagondrug
Nasal Glucagon 3 mgdrug