Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus (ReFLeCT)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec

Study type: Observational

Funder types: Industry

Identifiers

NCT02392117

NN1250-4189

U1111-1158-0248 (Other Identifier)

ENCEPP/SDPP/7880 (Other Identifier)

Details and patient eligibility

About

This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.

Enrollment: 1,262 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 procedure related to recording of data according to the protocol)
• Male or female patients at least 18 years of age at time of informed consent
• T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study
• Planned initiation with Tresiba®

Exclusion criteria

• Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products
• Previous participation in this study (i.e. provision of informed consent)
• Patients who have previously been treated with Tresiba®
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Trial design

1,262 participants in 1 patient group

Insulin degludec

Treatment:

Drug: insulin degludec