NCT03667053

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

Phase 3, Randomized, Double-blind, Placebo/Active-controlled, Parallel-arm Trial to Assess Efficacy, Safety, and Pharmacokinetics of Dasiglucagon Relative to Placebo/GlucaGen® as Rescue Therapy for Severe Hypoglycemia in Children With T1DM Treated With Insulin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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

Detailed description

At least 40 children ≥6 years and \<18 years of age with T1DM were planned to be randomized into the trial (2:1:1 for dasiglucagon:placebo:GlucaGen) and stratified by age intervals: 6 years to \<12 years, and 12 years to \<18 years; and by injection site (abdomen or thigh). A minimum of 16 patients were enrolled into each age group, including a minimum of 8 patients in each age group in the dasiglucagon treatment arm. In Germany only, a staggered approach was applied, whereby a positive safety assessment needed to be available for at least 10 patients in the age group of 12 years to \<18 years who had completed the dosing visit in the overall trial before younger patients (6 to 11 years of age) were allowed to be enrolled.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	dasiglucagon	glucagon analog
DRUG	placebo	placebo for dasiglucagon
DRUG	GlucaGen HypoKit	native glucagon

Timeline

• Start date: 2018-09-28
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2018-09-12
• Last updated: 2021-06-30
• Results posted: 2021-05-10

Locations

5 sites across 3 countries: United States, Germany, Slovenia

Regulatory

• FDA-regulated drug study