A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus

Novo Nordisk A/S1 site in 1 country1,262 target enrollmentMarch 16, 2015

ConditionsDiabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventionsinsulin degludec

Drugsinsulin degludec

Overview

Phase: Not Applicable
Intervention: insulin degludec
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 1262
Locations: 1
Primary Endpoint: Change in the number of any hypoglycaemic episodes
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 16, 2015

End Date

March 19, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Insulin degludec

Intervention: insulin degludec

Outcomes

Primary Outcomes

Change in the number of any hypoglycaemic episodes

Time Frame: End of 4 week baseline period, end of 12 month observation period

Secondary Outcomes

Change from baseline in HbA1c (glycosylated haemoglobin)(0- 12 months)
Change from baseline in FPG (Fasting Plasma Glucose)(0-12 months)
Change from the baseline period in the number of severe hypoglycaemic episodes(0-12 months)
Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire ))(0-12 months)