Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

NCT ID: NCT05076292

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2023-08-08

Brief Summary

The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).

The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.

Detailed Description

A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo.

During the visits and in an outpatient period the participants will have 3 different CGM devices installed and the values will be compared with self-monitored blood glucose values.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

Type 1 Diabetes; Exercise; Hypoglycemia; Glucagon; Continuous Glucose Monitoring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

150 ug glucagon before exercise

150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise.

Group Type: EXPERIMENTAL

GlucaGen

Intervention Type: DRUG

150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.

2*75 ug glucagon before exercise and after exercise

75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise.

Group Type: EXPERIMENTAL

GlucaGen

Intervention Type: DRUG

150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.

Saline as placebo

Saline as placebo will be administered in the same amount as glucagon before and after exercise.

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DRUG

Saline will be used as placebo before and after exercise.

Interventions

GlucaGen

150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.

Intervention Type: DRUG

Saline

Saline will be used as placebo before and after exercise.

Intervention Type: DRUG

Other Intervention Names

Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01; ATC-code: Natriumklorid isotonisk "BAUER" B05BB01, V07AB

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sissel B Lundemose, MD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

Sissel Banner Lundemose

Gentofte Municipality, , Denmark

Countries

Denmark

Other Identifiers

2021-001342-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

78618

Identifier Type: -

Identifier Source: org_study_id