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

Sponsor
Steno Diabetes Center Copenhagen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076292
Collaborator
(none)
22
Enrollment
1
Location
3
Arms
14
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A randomized, single-blinded, placebo-controlled three-arm cross-over studyA randomized, single-blinded, placebo-controlled three-arm cross-over study
Masking:
Single (Participant)
Masking Description:
Single-blinded
Primary Purpose:
Prevention
Official Title:
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: 150 ug glucagon before exercise

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

Drug: GlucaGen
150 ug or 75*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.
Other Names:
  • Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01
  • Experimental: 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.

    Drug: GlucaGen
    150 ug or 75*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.
    Other Names:
  • Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01
  • Active Comparator: Saline as placebo

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

    Drug: Saline
    Saline will be used as placebo before and after exercise.
    Other Names:
  • ATC-code: Natriumklorid isotonisk "BAUER" B05BB01, V07AB
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence rate of hypoglycemia (PG < 3.9 mmol/l) [From 0-180 minutes post-intervention]

    Secondary Outcome Measures

    1. Percentage of time below range (PG < 3.9) [From 0-180 minutes post-intervention]

    2. Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l) [From 0-180 minutes post-intervention]

    3. Time (min) to hypoglycemia (PG < 3.9 mmol/l) [From 0-180 minutes post-intervention]

    4. Change in plasma glucose levels [From 0-180 minutes post-intervention]

    5. Incidence rate of hyperglycemia (PG > 10 mmol/l) [From 0-180 minutes post-intervention]

    6. Nadir plasma glucose concentration [From 0-180 minutes post-intervention]

    7. Peak plasma glucose concentration [From 0-180 minutes post-intervention]

    8. Incremental peak in plasma glucose concentration [From 0-180 minutes post-intervention]

    9. Mean plasma glucose concentration [From 0-180 minutes post-intervention]

    10. Plasma glucose Area Under the Curve (AUC) [From 0 to 180 min post-intervention]

    11. Percentage of time in hyperglycemia (PG > 10 mmol/l) [From 0-180 minutes post-intervention]

    12. Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention [From 0-180 minutes post-intervention]

    13. Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value) [During exercise]

    14. MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value) [During the three-day outpatient period]

    15. MARD during the three-hour inpatient study visit (using YSI as reference value) [During exercise]

    16. Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value) [During exercise and during the three-day outpatient period]

    17. Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value) [During exercise and during the three-day outpatient period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Sissel Banner LundemoseGentofteDenmark2820

    Sponsors and Collaborators

    • Steno Diabetes Center Copenhagen

    Investigators

    • Principal Investigator: Sissel B Lundemose, MD, Steno Diabetes Center Copenhagen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steno Diabetes Center Copenhagen
    ClinicalTrials.gov Identifier:
    NCT05076292
    Other Study ID Numbers:
    • 78618
    • 2021-001342-34
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Steno Diabetes Center Copenhagen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2021