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:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT02505334
Eligibility Criteria:
Inclusion Criteria:
* Male or female Japanese subjects at least 20 years of age at the time of informed consent
* Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
* HbA1c 7.5-10.0% \[58 mmol/mol-86 mmol/mol\] (both inclusive)
* Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling
Exclusion Criteria:
* Treatment with insulin within 12 weeks 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 60 days before screening
* Screening calcitonin equal or above 50 ng/l
* History of pancreatitis (acute or chronic)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
* Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
* Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
* Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02505334
Study Brief:
Protocol Section:
NCT02505334