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

NCT03667053 PHASE3 COMPLETED Results posted

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

Details

Lead sponsor	Zealand Pharma
Phase	PHASE3
Status	COMPLETED
Enrolment	42
Start date	Fri Sep 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Jun 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Hypoglycemia

Interventions

• dasiglucagon
• placebo
• GlucaGen HypoKit

Countries

Slovenia, United States, Germany