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

NCT05076292 | Completed

• 2 other identifiers: 786182021-001342-34
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence rate of hypoglycemia (PG < 3.9 mmol/l)

  From 0-180 minutes post-intervention

Secondary Outcomes (17)

• Percentage of time below range (PG < 3.9)

  From 0-180 minutes post-intervention

• Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l)

  From 0-180 minutes post-intervention

• Time (min) to hypoglycemia (PG < 3.9 mmol/l)

  From 0-180 minutes post-intervention

• Change in plasma glucose levels

  From 0-180 minutes post-intervention

• Incidence rate of hyperglycemia (PG > 10 mmol/l)

  From 0-180 minutes post-intervention

Study Arms (3)

150 ug glucagon before exercise

EXPERIMENTAL

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

Drug: GlucaGen

2*75 ug glucagon before exercise and after exercise

EXPERIMENTAL

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

Drug: GlucaGen

Saline as placebo

ACTIVE COMPARATOR

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

Drug: Saline

Interventions

GlucaGen DRUG

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

Also known as: Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01

150 ug glucagon before exercise; 2*75 ug glucagon before exercise and after exercise

Saline DRUG

Saline will be used as placebo before and after exercise.

Also known as: ATC-code: Natriumklorid isotonisk "BAUER" B05BB01, V07AB

Saline as placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Sissel Banner Lundemose

Gentofte Municipality, 2820, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Interventions

Glucagon-Like Peptide 1; Glucagon; Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sissel B Lundemose, MD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single-blinded, placebo-controlled three-arm cross-over study

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 13, 2021
• Study Start: November 23, 2021
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)