The POST-PRANDIAL HYPO-AVOID STUDY Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People with Type 1 Diabetes

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Steno Diabetes Center Copenhagen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

10 Apr 2026 → ongoing

Decision date (initial)

2026-03-16

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate whether pre-exercise administration of low-dose subcutaneous glucagon prevents or attenuates exercise-induced declines in plasma glucose concentration during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes after a meal in adults with type 1 diabetes using an automated insulin delivery (AID) system.

Conditions and MedDRA coding

Type 1 Diabetes Mellitus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age more than 18 years old
2. Type 1 diabetes > 2 years
3. Use of automated insulin delivery system for equal to or more than 3 months
4. Treated with NovoRapid or Fiasp for at least one week priro to enrolment
5. Proefficiency in carbohydrate counting

Exclusion criteria 8

1. Allergies to lactose or glucagon
2. Known or suspected allergies to glucagon or related products
3. History of hypersensitivity or allergic reaction to glucagon or lactose
4. Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis
5. 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
6. Lack of compliance with key study procedures at the discretion of the investigator
7. 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)
8. Inability to understand the individual information and to give informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in plasma glucose (PG) from exercise initiation to the nadir during exercise and throughout the 2-hour post-exercise period.

Secondary endpoints 13

1. Percent PG time in range (3.9–10.0 mmol/L) from exercise onset to +120 min (continuous)
2. Incidence of hypoglycemia (PG <3.9 mmol/L; 0–180 min (binary)
3. Time to hypoglycemia (PG <3.9 mmol/L; 0–180 min).
4. Percent time below range (PG <3.9 mmol/L; 0–180 min) (continuous)
5. Percent time above range (PG >10.0 mmol/L; 0–180 min, (continuous)
6. Incidence of hyperglycemia (PG >10.0 mmol/L; 0–180 min) (binary)
7. Nadir PG concentration (0–180 min) (continuous)
8. Peak PG concentration (0–180 min) (continuous)
9. Incremental peak PG concentration (0–180 min) (continuous)
10. Mean PG concentration (0–180 min) (continuous)
11. PG area under the curve (AUC; 0–180 min) (continuous)
12. Standard deviation of PG (0–180 min) (continuous)
13. Coefficient of variation of PG (0–180 min) (continuous)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Steno Diabetes Center Copenhagen

Sponsor organisation

Steno Diabetes Center Copenhagen

Address

Borgmester Ib Juuls Vej 83

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Emilie Lindkvist

Public contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Emilie Lindkvist

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications