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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT04892069
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female, age above or equal to 18 years at the time of signing the informed consent.
* Patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
* Patients who were not achieving optimal glycaemic control and who required intensification of antidiabetic treatment and Ryzodeg was the treatment of choice.
* Available and documented HbA1c value at less or equal to 12 weeks prior to initiation of Ryzodeg® treatment and end of study within the study windows.
* Available and documented follow up time of at least 52 weeks with 26 weeks follow-up prior to and after initiation of Ryzodeg®.
* The decision to initiate treatment with commercially available Ryzodeg® 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.
Exclusion Criteria:
* Previous participation in this study. Participation is defined as signed informed consent.
* Participation in any clinical study of an approved or non-approved investigational medicinal product within 26 weeks before and after initiation of treatment with Ryzodeg®.
* Having been previously treated with Ryzodeg® prior to study start.
* Female who were pregnant or breast-feeding during the study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04892069
Study Brief:
Protocol Section:
NCT04892069