Status:
COMPLETED
China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect information on how Ryzodeg® works in real-world patients. Participants will get Ryzodeg® as prescribed to by their doctor. The study will last for about 5-8 mo...
Eligibility Criteria
Inclusion
- 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 initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on the approved Ryzodeg® label in China and independently from the decision to include the patient in this study.
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 20 weeks prior to Treatment Initiation Visit (Visit 1).
- Available and documented Glycosylated haemoglobin (HbA1c) value below or equal to 12 weeks prior to Informed Consent and Treatment Initiation Visit (Visit 1).
Exclusion
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Treatment with any investigational drug within 30 days prior to enrolment into the study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Ryzodeg® label in China.
Key Trial Info
Start Date :
March 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
887 Patients enrolled
Trial Details
Trial ID
NCT05221580
Start Date
March 18 2022
End Date
March 31 2023
Last Update
June 14 2024
Active Locations (50)
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1
NIS-The Second People's Hospital of Hefei
Hefei, Anhui, China, 230012
2
NIS-Beijing Hospital
Beijing, Beijing Municipality, China, 100005
3
NIS-Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
4
NIS-People's Hospital of Chongqing Banan District
Chongqing, Chongqing Municipality, China, 400320