Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Bloo… (NCT06588504) | Clinical Trial Compass
CompletedPhase 1
Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents
Japan38 participantsStarted 2024-09-10
Plain-language summary
This study will be looking to confirm the effect of dasiglucagon when compared with glucagon for treating very low sugar levels in Asian adults with T1D and the effect of dasiglucagon in Japanese adolescents with T1D. This study wants to demonstrate that dasiglucagon can raise low blood sugar levels just as well as glucagon. Participants will get dasiglucagon and glucagon. In which treatment order participants get study medicines (dasiglucagon and glucagon) is decided by chance. Dasiglucagon is a new medicine, but doctors can prescribe it in the US as it is approved there. Doctors can prescribe glucagon in multiple countries including Japan as an approved medicine. The study will last for about 17 weeks. Participant cannot be in the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding, plan to get pregnant, during the study period, or not using adequate contraceptive methods. For man: if participant have sex, participant and his partner must use an adequate birth control method during the study.
Who can participate
Age range
12 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* For Adults: Asian male or female; For Adolescents: Japanese male or female.
* Age at the time of signing the informed consent:
For Adults: Age 18-75 years (both inclusive):
For Adolescents: Age 12-15 years (both inclusive).
* Diagnosed with T1D greater than (\>)1 year before screening.
* Glycated haemoglobin (HbA1c) less than (\<)10.0 percentage (%) (86 millimoles per mole \[mmol/mol\]) as assessed by subcontracted laboratory by the site on the day of screening.
* For adults: BMI between 18.5 and 29.9 kilogram per meter square (kg/m2) (both inclusive).
For adolescents: Body weight greater than or equal to (≥) 33.4 kilograms (kg).
* Treated with stable insulin treatment (based on the investigator's discretion preferably no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening.
* For Japanese participants: Japanese passport or equivalent For non-Japanese participants: Asian (non- Japanese passport or equivalent).
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products (glucagon or its derivatives).
* Exposure to an investigational medicinal product (IMP) within 30 days or 5 times the half-life of the IMP (if known), whichever is longest before screening.
* Severe hypoglycaemia in the last month prior to screening.
* Hospitalisation for diabetic ketoacidosis (DKA) in the last month prior to screening.
* Presence or history of any clinically relevant respiratory, met…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adults cohort: Time to plasma glucose (PG) recovery, where PG recovery is defined as the first increase in PG of greater than or equal to (>=) 20 milligrams per decilitre (mg/dL) (1.1 millimoles per litre [mmol/L]) from baseline
Timeframe: From 0 to 90 minutes after investigational medicinal product (IMP) injection