A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
Status:
Completed
Trial end date:
2021-06-23
Target enrollment:
Participant gender:
Summary
This study is investigating the safety and tolerability of the new investigational product
NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the
treatment of diabetes. The study consists of 3 parts. The first part of the study is
conducted in healthy people, while the second part involves people with type 1 diabetes
(T1D). Part 3 of this trial involves also people with T1D.
The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the
blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers
will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants
with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also
decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants
will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left
thigh. Participation in the study will last for up to 6 weeks. There will be one Informed
Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood
sampling to measure blood sugar and the concentration of the investigational product in the
blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar
is measured and controlled for up to 42 hours.
For Part 3, the total duration of the trial for each individual is expected to be
approximately 3-9 weeks.
Participants cannot be in the study if the study doctor thinks that there are risks for their
health. Women can only take part in the study if they are of non-child bearing potential.