drugset / Trial / NCT03667053

Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

NCT03667053

Phase 3 Completed 42 enrolled Zealand Pharma
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2018-09-28
Primary completion
2019-06-28
Completion
2019-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Dasiglucagon Peptide Subcutaneous
Comparator Glucagon Peptide Subcutaneous

Indications