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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT01796366
Eligibility Criteria:
Inclusion Criteria:
* Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L)
* Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive)
* Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more
Exclusion Criteria:
* Known or suspected hypersensitivity to trial products or related products
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the Investigator
* Any chronic disorder or severe disease which in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01796366
Study Brief:
Protocol Section:
NCT01796366