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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04136067
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening.
* Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Current total daily insulin treatment between 0.25 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
* HbA1c equal to or below 9.5%
Exclusion Criteria:
* Male of reproductive age who, or whose partner(s), is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
* Use of GLP-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04136067
Study Brief:
Protocol Section:
NCT04136067