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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 13 (50 locations)

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