Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

Summary

A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo

Timeline

Start

2018-11-01

Primary completion

2019-03-11

Completion

2019-03-11

Outcome

Met primary endpoint

registry MEDIAN Dasiglucagon 0.6 mg: 10.0 (8.0 to 12.0) minutes NCT03688711 ↗

registry analysis (superiority test); Dasiglucagon 0.6 mg vs Placebo; p <0.0001; Log Rank NCT03688711 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dasiglucagon	Peptide	0.6 mg	Subcutaneous

Indications