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

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ClinicalTrials.gov Identifier: NCT05076292
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

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 disease Intervention/treatment Phase
Type 1 Diabetes Hypoglycemia Drug: GlucaGen Drug: Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A 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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/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 Name: 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 Name: 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 Name: ATC-code: Natriumklorid isotonisk "BAUER" B05BB01, V07AB




Primary Outcome Measures :
  1. Incidence rate of hypoglycemia (PG < 3.9 mmol/l) [ Time Frame: From 0-180 minutes post-intervention ]

Secondary Outcome Measures :
  1. Percentage of time below range (PG < 3.9) [ Time Frame: From 0-180 minutes post-intervention ]
  2. Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l) [ Time Frame: From 0-180 minutes post-intervention ]
  3. Time (min) to hypoglycemia (PG < 3.9 mmol/l) [ Time Frame: From 0-180 minutes post-intervention ]
  4. Change in plasma glucose levels [ Time Frame: From 0-180 minutes post-intervention ]
  5. Incidence rate of hyperglycemia (PG > 10 mmol/l) [ Time Frame: From 0-180 minutes post-intervention ]
  6. Nadir plasma glucose concentration [ Time Frame: From 0-180 minutes post-intervention ]
  7. Peak plasma glucose concentration [ Time Frame: From 0-180 minutes post-intervention ]
  8. Incremental peak in plasma glucose concentration [ Time Frame: From 0-180 minutes post-intervention ]
  9. Mean plasma glucose concentration [ Time Frame: From 0-180 minutes post-intervention ]
  10. Plasma glucose Area Under the Curve (AUC) [ Time Frame: From 0 to 180 min post-intervention ]
  11. Percentage of time in hyperglycemia (PG > 10 mmol/l) [ Time Frame: 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 [ Time Frame: From 0-180 minutes post-intervention ]
  13. Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value) [ Time Frame: During exercise ]
  14. MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value) [ Time Frame: During the three-day outpatient period ]
  15. MARD during the three-hour inpatient study visit (using YSI as reference value) [ Time Frame: During exercise ]
  16. Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value) [ Time Frame: 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) [ Time Frame: During exercise and during the three-day outpatient period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076292


Contacts
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Contact: Sissel B Lundemose, MD 24846602 sissel.lundemose@regionh.dk

Locations
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Denmark
Sissel Banner Lundemose Recruiting
Gentofte, Denmark, 2820
Contact: Sissel B Lundemose, MD    24846602    sissel.lundemose@regionh.dk   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Investigators
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Principal Investigator: Sissel B Lundemose, MD Steno Diabetes Center Copenhagen
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Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT05076292    
Other Study ID Numbers: 78618
2021-001342-34 ( EudraCT Number )
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Type 1 Diabetes
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs