drugset / Trial / NCT05454709

A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System

NCT05454709

Phase 2 Withdrawn Inreda Diabetic B.V.
RandomizedCrossoverQuadruple-blindOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dasiglucagon Peptide Subcutaneous
Comparator Glucagon Peptide Subcutaneous