At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 112 enrolled
Drug / intervention
dasiglucagon +1 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 Group Safety Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen® Administered Subcutaneously in Patients With Type 1 Diabetes Mellitus (T1DM)
In Brief
A Phase 3 clinical trial evaluating dasiglucagon and GlucaGen for Hypoglycemia and Diabetes Mellitus, Type 1. Completed, enrolled 112 participants across 7 sites in 4 countries.
Detailed Summary
The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon\* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon and GlucaGen. \*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoglycemia, Diabetes Mellitus, Type 1
CountriesAustria, Canada, Germany, United States
CollaboratorsSynteractHCR
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedJul 2017
Primary CompletionFeb 2018
TodayJul 2026
First PostedJul 13, 2017
Enrollment StartJun 28, 2017
Primary CompletionFeb 13, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.0 years ago
Interventions
dasiglucagondrug
Glucagon Analog
GlucaGendrug
Native Glucagon