A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice (ARISE)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Degludec/Insulin Aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT04042441

NN5401-4525

U1111-1227-8654 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.

Enrollment: 1,122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol.
• The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, 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 26 weeks prior to signing informed consent.
• Available and documented HbA1c value for 12 weeks or less prior to signing informed consent.

Exclusion criteria

• Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label.
• Previous participation in this study. Participation is defined as signed informed consent.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• Previous treatment with Ryzodeg®.

Trial design

1,122 participants in 1 patient group

Ryzodeg® as per local practice

Description:

Real-world population of patients with Diabetes Mellitus, Type 2 (T2DM), who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice.

Treatment:

Drug: Insulin Degludec/Insulin Aspart