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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT05755360
Eligibility Criteria:
Inclusion Criteria:
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to switch from DPP4i treatment to commercially available oral semaglutide has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study
* Participant with last measurement of HbA1c \>= 7.5% at informed consent and treatment initiation visit (V1) or less than or equal to (\<=) 90 days before informed consent and treatment initiation visit (V1)
* Treatment naïve to insulin. An exception is short-term insulin treatment for acute illness for a total of \< 14 days
Exclusion Criteria:
* Previous participation in this study. Participation is defined as having given informed consent in this study
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the informed consent and treatment initiation visit (V1) and throughout the duration of the study
* Participants with type-1 diabetes
* Participants who are pregnant or who become pregnant (or who plan to become pregnant) during the study period
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Age \< 18 years on the informed consent and treatment initiation visit (V1)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05755360
Study Brief:
Protocol Section:
NCT05755360