NCT03216226

A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus

A Phase 3, Randomized, Double-Blind, Parallel Group Safety Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen® Administered Subcutaneously in Patients With Type 1 Diabetes Mellitus (T1DM)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon\* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon and GlucaGen. \*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207

Detailed description

Patients with T1DM were randomly assigned in a 1:1 ratio to receive 3 SC injections of either dasiglucagon (0.6 mg) or GlucaGen (1 mg), with 1 week between doses. Patients were followed for 15 weeks from the day of the first dose to assess the immune response. Patients with previous exogenic glucagon exposure were not excluded from the trial, but the information on previous glucagon administration was recorded to enable subgroup analyses. It was expected that 112 patients in total would be randomly assigned to treatment groups and treated. A total of 90 patients were expected to complete the trial (45 in each treatment arm). To qualify as completed, the patient had to be dosed according to the procedure described in the protocol and to have blood drawn for the antidrug antibody analyses as scheduled.

Conditions

• Hypoglycemia
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	dasiglucagon	Glucagon Analog
DRUG	GlucaGen	Native Glucagon

Timeline

• Start date: 2017-06-28
• Primary completion: 2018-02-13
• Completion: 2018-02-13
• First posted: 2017-07-13
• Last updated: 2021-05-04
• Results posted: 2021-02-16

Locations

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

Regulatory

• FDA-regulated drug study