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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT06288412
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female.
* Age 18-75 years (both inclusive) at the time of signing the informed consent.
* Body mass index between 18.0 and 38.0 kilogram per meter\^2 (kg/m\^2) (both inclusive).
* Glycated hemoglobin (HbA1c) less than or equal to (\<=) 9 percent (75 millimoles per mole \[mmol/mol\]) at screening.
* Treated with basal insulin with or without any of the following anti-diabetic drugs/regimens with stable doses \>= 90 days prior to the day of screening:
* Metformin,
* Dipeptidyl peptidase 4 (DPP-4) inhibitors,
* Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors
* Oral combination products (for the allowed individual oral antidiabetic drugs), Injectable and oral glucagon-like peptide 1 (GLP-1) Receptor Agonists.
* Physically active \>= 300 metabolic equivalent of task (MET) minutes/week as determined by an International Physical Activity Questionnaire (IPAQ) at screening.
* Mass-specific oxygen volume (VO2) peak greater than (\>) 25 milliliters per kilogram per minute (mL/kg/min) as determined by cardiopulmonary testing (CPX) test at screening.
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* 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 within 180 days prior to the day of screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06288412
Study Brief:
Protocol Section:
NCT06288412