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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec

• Registration Number: NCT02392117
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-12
• Study Start: 2015-03-16
• Study First Posted: 2015-03-18
• Primary Completion: 2018-03-19
• Study Completion: 2018-03-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1262

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin degludec	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Change in the number of any hypoglycaemic episodes	End of 4 week baseline period, end of 12 month observation period

Secondary Outcome Measures

Name	Time	Method
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
Change from baseline in HbA1c (glycosylated haemoglobin)	0- 12 months

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 London, United Kingdom