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NCT Number: NCT02392117

Investigating the Safety and Effectiveness of Insulin Degludec 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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

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.

Primary outcomes

  1. Change in the number of any hypoglycaemic episodes

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

Secondary outcomes

  1. Change from baseline in HbA1c (glycosylated haemoglobin)

    Time frame: 0- 12 months

  2. Change from baseline in FPG (Fasting Plasma Glucose)

    Time frame: 0-12 months

  3. Change from the baseline period in the number of severe hypoglycaemic episodes

    Time frame: 0-12 months

  4. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: ReFLeCT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2015
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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