A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inreda Diabetic B.V.
• Treatments: Glucagon

Criteria

Inclusion Criteria:

• Diagnosed with diabetes mellitus type 1;

• Treated with the Inreda AP system for a minimum of 1 month;

• Age between 18 and 75 years;

• Adequate contraception is required (only applicable for female participants);

• Willing and able to sign informed consent.

Since subjects are treated with the Inreda AP, the following inclusion criteria will be met:

• Treated with SAP or CSII for a minimum of 6 months;

• HbA1c < 97 mmol/mol;

• BMI < 35 kg/m2;

• No use of acetaminophen, as this may influence the sensor glucose measurements.

Exclusion Criteria:

• Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire [3], [4];

• Pregnancy and/or breastfeeding;

• Use of oral antidiabetic agents;

• Pheochromocytoma;

• Insulinoma;

• Severe liver/heart/renal failure;

• Alcohol abuse;

• Hypersensitivity reactions to dasiglucagon, glucagon or any of the excipients;