China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Ryzodeg®

Study type: Observational

Funder types: Industry

Identifiers

NCT05221580

NN5401-4623

U1111-1238-6960 (Other Identifier)

Details and patient eligibility

About

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 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment

Enrollment: 887 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. 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.
3. Male or female, age above or equal to 18 years at the time of signing informed consent.
4. 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).
5. Available and documented Glycosylated haemoglobin (HbA1c) value below or equal to 12 weeks prior to Informed Consent and Treatment Initiation Visit (Visit 1).

Exclusion criteria

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Treatment with any investigational drug within 30 days prior to enrolment into the study.
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Ryzodeg® label in China.

Trial design

887 participants in 1 patient group

Real-world adult population of Chinese patients with T2DM

Description:

Ryzodec as per local clinical practise

Treatment:

Drug: Ryzodeg®