NCT03378635

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

A Phase 3, Randomized, Double-blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus Compared to Placebo and With Reference to GlucaGen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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®.

Detailed description

This was a global, multicenter, randomized, parallel, and double-blind clinical trial confirming the efficacy and safety of dasiglucagon for insulin-induced hypoglycemia in patients with T1DM. The patients were randomized 2:1:1 to receive a single subcutaneous 0.6 mg dose of dasiglucagon, placebo, or a 1 mg dose of GlucaGen and followed for at least 28 days after receiving treatment.

Conditions

• Hypoglycemia
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Dasiglucagon	Glucagon analog
DRUG	GlucaGen	Native glucagon
DRUG	Placebo	Placebo for dasiglucagon

Timeline

• Start date: 2017-12-07
• Primary completion: 2018-04-27
• Completion: 2018-05-25
• First posted: 2017-12-20
• Last updated: 2021-06-10
• Results posted: 2021-05-10

Locations

5 sites across 4 countries: United States, Austria, Canada, Germany

Regulatory

• FDA-regulated drug study