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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT03070704
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. Some specific historical data collected before informed consent is obtained can be used as baseline data (HbA1c, FPG/FBG and others)
* The decision to initiate treatment with commercially available Xultophy™ has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age at least 18 years at the time of signing the informed consent
* Patients diagnosed with type 2 diabetes mellitus
* Patients who are scheduled to start treatment with Xultophy™ based on the clinical judgement of their treating physician
Exclusion Criteria:
* Known or suspected hypersensitivity to Xultophy™, any of the active substances, any of the excipients or any related products
* Previous participation in this study. Participation is defined as signed informed consent
* Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation
* Females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months
* Patients who are participating in other studies or clinical trials.
* Any disorder which in the opinion of the Physician might jeopardise subject's safety or compliance with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03070704
Study Brief:
Protocol Section:
NCT03070704