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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT04582435
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Aged 18-75 years (both inclusive) at the time of signing informed consent
* Body mass index between 18.0 and 38.0 kg/m\^2 (both inclusive)
* HbA1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening
* Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) Any metformin formulation 2) Other oral antidiabetic drugs: DPP-4 nhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
* Oral or injectable GLP-1 Receptor Agonists
Exclusion Criteria:
* Known or suspected hypersensitivity to trial product(s) or related products
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04582435
Study Brief:
Protocol Section:
NCT04582435