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

September 30, 2019 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Århus, Denmark, 8200
        • Novo Nordisk Investigational Site
  • Germany
      • München, Germany, 81925
        • Novo Nordisk Investigational Site
  • Italy
      • Padova, Italy, 35122
        • Novo Nordisk Investigational Site
  • Netherlands
      • Utrecht, Netherlands, 3508 GA
        • Novo Nordisk Investigational Site
  • Spain
      • Palma de Mallorca, Spain, 07015
        • Novo Nordisk Investigational Site
  • Sweden
      • Karlstad, Sweden, 651 85
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male or female patients aged at least 18 years of age with either T1DM or T2DM (insulin using) (clinically diagnosed) prior to visit 1, who signed an informed consent form, and whose physician plans to start Tresiba® treatment are eligible for entry in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insulin degludec
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the number of any hypoglycaemic episodes
Time Frame: End of 4 week baseline period, end of 12 month observation period
End of 4 week baseline period, end of 12 month observation period

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c (glycosylated haemoglobin)
Time Frame: 0- 12 months
0- 12 months
Change from baseline in FPG (Fasting Plasma Glucose)
Time Frame: 0-12 months
0-12 months
Change from the baseline period in the number of severe hypoglycaemic episodes
Time Frame: 0-12 months
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 ))
Time Frame: 0-12 months
0-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2015

Primary Completion (Actual)

March 19, 2018

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-4189
  • U1111-1158-0248 (Other Identifier: WHO)
  • ENCEPP/SDPP/7880 (Other Identifier: EU PAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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