a new kind of glucagon for the artificial pancreas

Phase 1

• Conditions: Type 1 Diabetes mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2022-000427-20-NL
• Lead Sponsor: Inreda Diabetic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-16
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

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);

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

• Impaired awareness of hypoglycemia
• Pregnancy and/or breastfeeding;
• Use of oral antidiabetic agents;
• Pheochromocytoma;
• Insulinoma;
• Severe liver/heart/renal failure;
• Alcohol abuse;
• Hypersensitivity reactions to dasiglucagon.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to determine the feasibility of dasiglucagon in the Inreda AP-system. ;Secondary Objective: Secondary objectives are to assess safety parameters, differences in pharmacodynamics between dasiglucagon and GlucaGen® and differences in AP related outcomes.;Primary end point(s): Main parameter to express feasibility is the time in range (3.9 – 10.0 mmol/l), which will be compared between the dasiglucagon and reference glucagon.;Timepoint(s) of evaluation of this end point: End of the study

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: End of the study;Secondary end point(s): Safety will be expressed as side effects of dasiglucagon compared to side effects of GlucaGen.<br><br>Pharmacodynamics will be expressed in proportion of time spent in hypo-/hyperglycemia, median/mean glucose value, glycemic variability and PD curves, which will all be compared between the dasiglucagon and reference glucagon.<br><br>AP related outcomes will be expressed in daily administered (maintenance) dosage of insulin/glucagon.