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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT05533632
Eligibility Criteria:
Inclusion Criteria:
* Participants diagnosed (clinically) with type 2 diabetes greater than equal to (≥) 90 days prior to the screening visit.
* Stable daily dose of Oral Antidiabetic Drug (OAD) and/or insulin treatment for ≥ 60 days prior to the screening visit.
* HbA1c 7.5-10% (59-86 millimoles per mole \[mmol/mol\]) (both inclusive) in Visit 1.
* Participants in which Ozempic is indicated according to approved local label.
* Fundoscopy/Fundus photography record less than equal to (≤) 12 months.
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous participation in this study. Participation is defined as signed informed consent.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before the screening visit, except Coronavirus Disease 2019 (COVID-19) related trials (this is allowed).
* Treatment with any glucagon-like peptide-1 receptor agonists (GLP-1 RA) medication prior to the screening visit.
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
* History of pancreatitis (acute or chronic).
* Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 milliliters/minute (mL/min)/1.73 meter square (m\^2) as per MDRD-4 (Modification of Diet in Renal Disease).
* Myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
* Participants presently classified as being in New York Heart Association (NYHA) Class IV heart failure.
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
* Participants with alanine aminotransferase (ALT) \> 2.5 x upper normal limit (UNL).
* Use of systemic immunosuppressive treatment within 90 days prior to screening.
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of ≤ 14 days.
* Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.
* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 12 months prior to screening.
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05533632
Study Brief:
Protocol Section:
NCT05533632