drugset / Trial / NCT05454709
A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dasiglucagon | Peptide | — | Subcutaneous |
| Comparator | Glucagon | Peptide | — | Subcutaneous |