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

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

Outcome

Met primary endpoint

registry MEDIAN Dasiglucagon 0.6 mg: 10.00 (8.00 to 12.00) minutes NCT03667053 ↗

registry analysis (superiority test); Dasiglucagon 0.6 mg vs Placebo; p <0.001; Log Rank NCT03667053 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dasiglucagon	Peptide	—	Subcutaneous
Comparator	Glucagon	Peptide	—	Subcutaneous

Indications