MedTrace Logo

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

NCT03216226 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-05-04

Study results available
· View outcomes & findings →

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

Conditions

Interventions

DRUG

dasiglucagon

Glucagon Analog

DRUG

GlucaGen

Native Glucagon

Sponsors & Collaborators

Principal Investigators

  • Christina Sylvest, MSc Pharm · Zealand Pharma A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2018-02-13
Completion
2018-02-13
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216226 on ClinicalTrials.gov