At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 129 enrolled
Drug / intervention
Nasal Glucagondrug
Likely dose
Nasal Glucagon 3 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 Multiple Center, Open Label, Prospective, Observational Study to Evaluate the Effectiveness and Ease-of-Use of AMG504-1 Administered in the Home or Work Environments for Treating Episodes of Hypoglycemia in Patients With Type 1 Diabetes
In Brief
A Phase 3 clinical trial evaluating Nasal Glucagon for Hypoglycemia and 2 related conditions. Completed, enrolled 129 participants across 9 sites in 2 countries.
Detailed Summary
Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies
CountriesCanada, United States
CollaboratorsLocemia Solutions ULC
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedJun 2014
Primary CompletionAug 2015
TodayJul 2026
First PostedJun 24, 2014
Enrollment StartMay 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.0 years ago
Interventions
Nasal Glucagondrug
3 mg nasal glucagon powder