A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec

Study type: Observational

Funder types: Industry

Identifiers

NCT04315688

U1111-1236-4887 (Other Identifier)

NN1250-4589

Details and patient eligibility

About

The purpose of the study is to collect information on how Tresiba® works in real world patients with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 6 to 8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 Tresiba® has been made by the patient and the treating physician 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 type 2 diabetes and treated with any antihyperglycemic medication(s), except Tresiba® (insulin degludec), for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1).
• Available and documented HbA1c value 12 weeks or less prior to initiation of Tresiba® treatment.

Exclusion criteria

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

Trial design

494 participants in 1 patient group

Tresiba®

Description:

Patients with type 2 diabetes

Treatment:

Drug: insulin degludec