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

• Status: Completed
• Trial end date: 2018-03-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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