At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 42 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.
Phase 3, Randomized, Double-blind, Placebo/Active-controlled, Parallel-arm Trial to Assess Efficacy, Safety, and Pharmacokinetics of Dasiglucagon Relative to Placebo/GlucaGen® as Rescue Therapy for Severe Hypoglycemia in Children With T1DM Treated With Insulin
In Brief
A Phase 3 clinical trial evaluating dasiglucagon, placebo, and 1 other intervention for Hypoglycemia. Completed, enrolled 42 participants across 5 sites in 3 countries.
Detailed Summary
A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoglycemia
CountriesGermany, Slovenia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartSep 2018
Primary CompletionJun 2019
TodayJul 2026
First PostedSep 12, 2018
Enrollment StartSep 28, 2018
Primary CompletionJun 28, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.8 years ago
Interventions
dasiglucagondrug
glucagon analog
placebodrug
placebo for dasiglucagon
GlucaGen HypoKitdrug
native glucagon