Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02392117
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin degludec

Layout table for study information
Study Type : Observational
Actual Enrollment : 1259 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 16, 2015
Actual Primary Completion Date : March 19, 2018
Actual Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in the number of any hypoglycaemic episodes [ Time Frame: End of 4 week baseline period, end of 12 month observation period ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392117


Locations
Layout table for location information
Denmark
Novo Nordisk Investigational Site
Århus, Denmark, 8200
Germany
Novo Nordisk Investigational Site
München, Germany, 81925
Italy
Novo Nordisk Investigational Site
Padova, Italy, 35122
Netherlands
Novo Nordisk Investigational Site
Utrecht, Netherlands, 3508 GA
Spain
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07015
Sweden
Novo Nordisk Investigational Site
Karlstad, Sweden, 651 85
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Novo Nordisk A/S

Additional Information:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02392117     History of Changes
Other Study ID Numbers: NN1250-4189
U1111-1158-0248 ( Other Identifier: WHO )
ENCEPP/SDPP/7880 ( Other Identifier: EU PAS )
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs