Effect of Low-Dose Dasiglucagon and Automated Insulin Delivery on Exercise-Induced Hypoglycemia in Adults with Type 1 Diabetes Mellitus
- Trial ID
- 2025-523996-45-00
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy of pre-exercise administration of low-dose subcutaneous glucagon in preventing or attenuating declines in plasma glucose concentration. This assessment occurs during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes postprandially in adults with type 1 diabetes mellitus utilizing an automated insulin delivery (AID) system. 5, 4
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients with type 1 diabetes mellitus, including both males and females. Eligible individuals must have been diagnosed with the condition for more than two years and have utilized an automated insulin delivery system for a minimum of three months. Participants are required to have used NovoRapid or Fiasp for at least one week prior to enrollment and must demonstrate proficiency in carbohydrate counting.
Plans and Procedures
This study is designed to evaluate the efficacy of pre-exercise administration of low-dose subcutaneous glucagon in preventing or attenuating declines in plasma glucose concentration. The research focuses on adults with type 1 diabetes who utilize an automated insulin delivery system. The primary endpoint is the change in glucose levels from the start of exercise to the nadir during and after moderate-intensity continuous exercise performed approximately 90 minutes after a meal. Secondary endpoints include the incidence and time to hypoglycemia, as well as various metrics regarding time in range and glucose variability. The study involves the administration of either dasiglucagon or glucagon via subcutaneous injection to assess its impact on glucose regulation during supervised physical activity on a cycle ergometer.
Treatment
The experimental treatment involves the administration of dasiglucagon, provided as a 0.6 mg solution for injection in a pre-filled syringe. The administered dose is 1200 µg via subcutaneous injection.
The comparator treatment consists of glucagon, administered as a powder and solvent for solution for injection. The dosage is 2000 mg via subcutaneous injection.
Efficacy
The primary efficacy endpoint is the change in plasma glucose from the initiation of exercise to the nadir during exercise and throughout the 2-hour post-exercise period. Secondary endpoints include the percent time in range (3.9–10.0 mmol/L), the incidence and time to hypoglycemia (PG <3.9 mmol/L), the percent time below range (PG <3.9 mmol/L), and the percent time above range (PG >10.0 mmol/L) measured from exercise onset to 180 minutes.
Additional secondary parameters assessed from 0 to 180 minutes involve:
- Incidence of hyperglycemia (PG >10.0 mmol/L)
- Nadir PG concentration
- Peak PG concentration
- Incremental peak PG concentration
- Mean PG concentration
- PG area under the curve (AUC)
- Standard deviation of PG
- Coefficient of variation of PG
Inclusion and Exclusion Criteria
Inclusion Criteria
- Age more than 18 years old
- Type 1 diabetes > 2 years
- Use of automated insulin delivery system for equal to or more than 3 months
- Treated with NovoRapid or Fiasp for at least one week priro to enrolment
- Proefficiency in carbohydrate counting
Exclusion Criteria
- Allergies to lactose or glucagon
- Known or suspected allergies to glucagon or related products
- History of hypersensitivity or allergic reaction to glucagon or lactose
- Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis
- 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
- Lack of compliance with key study procedures at the discretion of the investigator
- 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 enrolment 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
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Denmark | Recruiting | 01 Mar 2026 | 18 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Zegalogue 0.6 mg solution for injection in pre-filled syringe | Test | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SUBCUTANEOUS INJECTION | 1200 | 1 | PRD11750756 |
GlucaGen HypoKit, pulver og solvens til injektionsvæske, opløsning | Test | PULVER OG SOLVENS TIL INJEKTIONSVÆSKE, OPLØSNING | SUBCUTANEOUS INJECTION | 2000 | 1 | PRD335539 |