At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 170 enrolled
Drug / intervention
Dasiglucagon +2 moredrug
Likely dose
Not stated in 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, Randomized, Double-blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus Compared to Placebo and With Reference to GlucaGen
In Brief
A Phase 3 clinical trial evaluating Dasiglucagon, GlucaGen, and 1 other intervention for Hypoglycemia and Diabetes Mellitus, Type 1. Completed, enrolled 170 participants across 5 sites in 4 countries.
Detailed Summary
The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus (T1DM) with insulin-induced hypoglycemia. Additionally to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoglycemia, Diabetes Mellitus, Type 1
CountriesAustria, Canada, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartDec 2017
First PostedDec 2017
Primary CompletionApr 2018
Study CompletionMay 2018
TodayJul 2026
First PostedDec 20, 2017
Enrollment StartDec 7, 2017
Primary CompletionApr 27, 2018
Study CompletionMay 25, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.5 years ago
Interventions
Dasiglucagondrug
Glucagon analog
GlucaGendrug
Native glucagon
Placebodrug
Placebo for dasiglucagon