drugset / Trial / NCT03378635

A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

NCT03378635

Phase 3 Completed 170 enrolled Zealand Pharma
RandomizedParallel-groupQuadruple-blindTreatment

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®.

Timeline

Start
2017-12-07
Primary completion
2018-04-27
Completion
2018-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Dasiglucagon Peptide 0.6 mg Subcutaneous
Comparator Glucagon Peptide 1 mg Subcutaneous