Glucagon for Prevention of Exercise-Induced 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: EUCTR2021-001342-34-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: 2021-06-21
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

•Age = 18
•T1D = 2 years
•Use of insulin pump or MDI therapy for = 6 months
•Current use of insulin aspart
•HbA1c = 70mmol/mol (8.5%)
•Body mass index (BMI) = 30 kg/m2
•Performs exercise = 1 time per week

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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
Professional athletes or highly active individuals (= 5 hours of exercise per week)
Known or suspected allergies to glucagon or related products
History of hypersensitivity or allergic reaction to glucagon or lactose
Allergy to the patch of the CGM devices
Patients with pheochromocytoma, insulinoma or gastroparesis
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
Inability to understand the individual information and to give informed consent
Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis 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