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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT04656106
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation
* Type 2 diabetes mellitus patients
* Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg®
* Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD)
* At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation
* Minimum available data : age, type of diabetes at the time of Ryzodeg® initiation, HbA1c \[Three values: most recent value within 26 weeks (plus/minus 6 weeks) prior to Ryzodeg® initiation, a value of Ryzodeg® initiation date (plus/minus 6 week), and a value in the first 26 weeks (plus/minus 6 weeks) after Ryzodeg® initiation\]
* The decision to treat with Ryzodeg® was taken by treating physician independently from decision to include patient in study.
Exclusion Criteria:
* Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg®
* Patients switching to Ryzodeg® below 26 weeks prior to the data collection date
* Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg®
* Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg®
* Pregnancy patient
* Patients not treated with the local licensed Ryzodeg®
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04656106
Study Brief:
Protocol Section:
NCT04656106