Status:
COMPLETED
Investigating the Effect of Ryzodeg® in Adult Patients With Type 2 Diabetes in Lebanon
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated hae...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 18 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04892069
Start Date
May 27 2021
End Date
November 18 2021
Last Update
November 14 2022
Active Locations (1)
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1
Novo Nordisk Investigational Site
Beirut, Hamra, Beyrouth, Lebanon, 00000