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A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM

NCT03176524 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-12-12

No results posted yet for this study

Summary

This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.

Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period.

The total trial maximum duration for the individual subject will be up to 10 weeks.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

BioChaperone® glucagon formulation 1

Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg

DRUG

BioChaperone® glucagon formulation 2

Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg

DRUG

GlucaGen® HypoKit®

Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Ulrike Hövelmann, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2017-09-04
Completion
2017-09-04

Countries

  • Germany

Study Locations

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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 NCT03176524 on ClinicalTrials.gov