Dasiglucagon for Prevention of Low Blood Glucose Levels in People with Type 1 Diabetes

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-000551-12-DK
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Age 18-64 years
•Type 1 diabetes = 3 years
•Use of continuous subcutaneous insulin infusion or multiple daily injection therapy for = 6 months
•HbA1c = 8.0%

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
•History of allergy or intolerance to glucagon or glucagon-like products
•Patients with pheochromocytoma
•Clinically significant ECG abnormalities
•Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
•Inability to understand the individual information and to give informed consent
•Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
•Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the individual unsuitable for study participation

Study & Design

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