Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT07087795
Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body mass index 22-35 kilogram per square meter (kg/m\^2) (both inclusive) for Part A and 27-35(kg/m\^2) (both inclusive) for Part B at the day of screening.
* Diagnosed with type 1 diabetes mellitus greater than equal to (≥) 1 year prior to the day of screening.
* Treated with multiple daily insulin injections and stable insulin dose greater than (\>) 90 days prior to the day of screening, as judged by the investigator.
* Use of Continuous glucose monitoring (CGM) device \> 180 consecutive days prior to the day of screening.
* Glycated haemoglobin (HbA1c) from 7.2 - 9.0% (both inclusive).
* Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* Ability and willingness to wear the Novo Nordisk provided CGM device according to the protocol including replacement of CGM sensor at home.
* Ability and willingness to refrain from wearing own CGM/Flash glucose monitor for the duration of the study, as judged by the investigator.
Exclusion Criteria:
* Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Treatment with glucagon-like peptide-1(GLP-1) RA within 90 days before screening.
* Use of any medication with unknown or unspecified content within 90 days before screening.
* Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days prior to the day of screening.
* Any episode of diabetic ketoacidosis within 90 days before screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT07087795
Study Brief:
Protocol Section:
NCT07087795