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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT04707469
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
* HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
* BMI equal to or above 25 kg/m\^2
* Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
* No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \*:
* Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
* Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
* Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
* Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
* Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).
Exclusion Criteria:
* Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04707469
Study Brief:
Protocol Section:
NCT04707469