RESILIENT: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in Local Clinical Practice in Japan

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Degludec/Insulin Aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT03745157

U1111-1208-5143 (Other Identifier)

NN5401-4441

Details and patient eligibility

About

The purpose of the study is to collect information on how Ryzodeg® works in real world participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.

Enrollment: 246 patients

Sex: All

Ages: 20+ 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 treatment with commercially available insulin Ryzodeg® has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study
• Male or female, age more than or equal to 20 years (the legal age of adulthood) at the time of signing informed consent
• Diagnosed with type 2 diabetes (T2D) for at least 26 weeks prior to signing informed consent
• Available and documented glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to initiation of Ryzodeg® treatment
• For at least 26 weeks prior to initiation of Ryzodeg® treatment, one of the following must apply: A) Treated with insulin glargine (IGlar) (any formulation, including biosimilar IGlar). B) Treated with IGlar (any formulation, including biosimilar IGlar) and IGlar U300 for at least 12 weeks prior to initiation of Ryzodeg®

Exclusion criteria

• Previous participation in this study. Participation is defined as signed informed consent.
• Pregnancy
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Hypersensitivity to Ryzodeg® or to any of the excipients
• Previously treated with Ryzodeg®

Trial design

246 participants in 1 patient group

Patients with Type 2 Diabetes requiring insulin therapy

Description:

Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar)

Treatment:

Drug: Insulin Degludec/Insulin Aspart