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NCT02392117 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— ReFLeCT  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02392117
Other study ID # NN1250-4189
Secondary ID U1111-1158-0248E
Status Completed
Phase
First received
Last updated
Start date March 16, 2015
Est. completion date March 19, 2018

Study information
Verified date September 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1262
Est. completion date March 19, 2018
Est. primary completion date March 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• insulin degludec
Tresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given.

Locations
Country Name City State
Denmark Novo Nordisk Investigational Site Århus
Germany Novo Nordisk Investigational Site München
Italy Novo Nordisk Investigational Site Padova
Netherlands Novo Nordisk Investigational Site Utrecht
Spain Novo Nordisk Investigational Site Palma de Mallorca
Sweden Novo Nordisk Investigational Site Karlstad
Switzerland Novo Nordisk Investigational Site Zürich
United Kingdom Novo Nordisk Investigational Site London

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

Fadini GP, Feher M, Hansen TK, de Valk HW, Koefoed MM, Wolden M, Zimmermann E, Jendle J. Switching to Degludec from Other Basal Insulins is Associated with Reduced Hypoglycemia Rates: a Prospective Study. J Clin Endocrinol Metab. 2019 Aug 9. pii: jc.2019- — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the number of any hypoglycaemic episodes End of 4 week baseline period, end of 12 month observation period
Secondary Change from baseline in HbA1c (glycosylated haemoglobin) 0- 12 months
Secondary Change from baseline in FPG (Fasting Plasma Glucose) 0-12 months
Secondary Change from the baseline period in the number of severe hypoglycaemic episodes 0-12 months
Secondary 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
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