Micro Glucagon During Exercise in Type 1 Diabetes

NCT04192019 | Withdrawn Early Phase 1

• 1 other identifier: GLU-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This proof-of-principle study to assess effects of different doses (mini and micro) of subcutaneous glucagon analog Dasiglucagon (Zealand Pharma, Copenhagen, Denmark) on the change in blood glucose concentration during moderate-intensity exercise in people with T1D.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

type 1 diabetes; glucagon; hypoglycemia; exercise; glycogen

Outcome Measures

Primary Outcomes (1)

• Time to hypoglycaemia

  Time (in minutes) to hypoglycaemia (plasma glucose \<3.9mmol/l) during 60 minutes of aerobic exercise in individuals with type 1 diabetes using mini and micro doses of Dasiglucagon compared to no Dasiglucagon

  60 minutes

Secondary Outcomes (8)

• Change in glycaemia during exercise

  60 minutes

• Glucose during exercise

  60 minutes

• Glucagon during exercise

  60 minutes

• Time in target

  24 hours

• Time in target during exercise

  60 minutes

Study Arms (3)

Micro-dose glucagon

EXPERIMENTAL

80 µg (micro-dose) subcutaneous Dasiglucagon 5 min before the start of exercise

Drug: Micro-glucagon

Mini-dose glucagon

EXPERIMENTAL

150 µg mini-dose of subcutaneous Dasiglucagon 5 min before exercise the start of exercise

Drug: Mini-glucagon

No treatment

NO INTERVENTION

No treatment before the start of exercise

Interventions

Micro-glucagon DRUG

Administration of 80 µg (micro-dose) subcutaneous Dasiglucagon 5 min before the start of exercise

Also known as: Dasiglucagon

Micro-dose glucagon

Mini-glucagon DRUG

Administration of 150 µg (mini-dose) subcutaneous Dasiglucagon 5 min before the start of exercise

Also known as: Dasiglucagon

Mini-dose glucagon

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• T1D for \>1 year
• Male aged 18-45 years old
• HbA1c \<8.0% (64 mmol/mol) based on analysis from the central laboratory unit of Bern University Hospital
• Regular physical activity (defined as meeting 150 min moderate-intensity exercise per week)
• Using either continuous subcutaneous insulin infusion or multiple daily injections
• Written informed consent

You may not qualify if:

• Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the results as judged by the investigator
• Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, SGLT2 inhibitors, GLP1 agonists
• Relevant diabetic complications as judged by the investigator
• Body mass index 30 kg/m2
• Uncontrolled hypertension (\>180/100 mmHg)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Interventions

dasiglucagon

Condition Hierarchy (Ancestors)

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

Study Officials

• Christoph Stettler, MD

  Clinic Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Time to hypoglycaemia during 60 minutes of aerobic exercise in individuals with type 1 diabetes using mini and micro doses of Dasiglucagon compared to no Dasiglucagon

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share