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A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System

NCT05454709 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-01-03

No results posted yet for this study

Summary

The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®.

This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Dasiglucagon

Use of dasiglucagon in the AP system.

DRUG

GlucaGen

Use of GlucaGen in the AP system.

Sponsors & Collaborators

  • Inreda Diabetic B.V.

    lead INDUSTRY

Principal Investigators

  • G Laverman, MD · ZGT hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-12-29
Primary Completion
2023-12-29
Completion
2023-12-29

Countries

  • Netherlands

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 NCT05454709 on ClinicalTrials.gov