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Investigating the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus (EU-TREAT)

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: NCT02662114
Recruitment Status : Completed
First Posted : January 25, 2016
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date December 4, 2015
First Posted Date January 25, 2016
Last Update Posted Date May 2, 2019
Actual Study Start Date December 8, 2015
Actual Primary Completion Date August 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2016)
Change in HbA1c after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 21, 2016)
  • Change in HbA1c after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
  • Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
  • Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
  • Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
  • Change in the mean FPG level after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
  • Tresiba® starting dose at switch and doses [ Time Frame: At 6 months ]
  • Tresiba® starting dose at switch and doses [ Time Frame: At 12 months ]
  • Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
  • Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
  • Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
  • Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
  • Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
  • Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
  • Change in body weight (kg) after switch to Tresiba® [ Time Frame: Month 0, Month 6 ]
  • Change in body weight (kg) after switch to Tresiba® [ Time Frame: Month 0, Month 12 ]
  • Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® [ Time Frame: -6 to 0 months ie 6 months before switch to Tresiba® ]
  • Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® [ Time Frame: 0 to +6 months ]
  • Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® [ Time Frame: -12 to 0 months ie 12 months before switch to Tresiba® ]
  • Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® [ Time Frame: 0 to +12 months ]
  • Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) [ Time Frame: -6 to 0 months ie 6 months before switch to Tresiba® ]
  • Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) [ Time Frame: 0 to +6 months ]
  • Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) [ Time Frame: -12 to 0 months ie 12 months before switch to Tresiba® ]
  • Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) [ Time Frame: 0 to +12 months ]
  • Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: -6 to 0 months ie 6 months before switch to Tresiba® ]
  • Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +6 months ]
  • Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: -12 to 0 months ie 12 months before switch to Tresiba® ]
  • Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +12 months ]
  • Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: -6 to 0 months (ie 6 months before switch to Tresiba®) ]
  • Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +6 months ]
  • Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: -12 to 0 months ie 12 months before switch to Tresiba® ]
  • Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +12 months ]
  • Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® [ Time Frame: -6 to 0 months ie 6 months before switch to Tresiba® ]
  • Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +6 months ]
  • Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® [ Time Frame: -12 to 0 months ie 12 months before switch to Tresiba® ]
  • Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® [ Time Frame: 0 to +12 months ]
  • Percentage of patients continuing Tresiba® post-switch [ Time Frame: At 6 months ]
  • Percentage of patients continuing Tresiba® post-switch [ Time Frame: At 12 months ]
  • Reason(s) for starting Tresiba®, if available [ Time Frame: Month 0, Month 12 ]
  • Reason(s) for discontinuing Tresiba®, if applicable and available [ Time Frame: Month 0, Month 12 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus
Official Title A European Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus
Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus.

EU-TREAT (EUropean TREsiba AudiT)

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population T1DM (Type 1 diabetes mellitus) and T2DM (Type 2 diabetes mellitus) patient sample treated with Tresiba® under conditions of routine care.
Condition
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Intervention Other: No treatment given
Information will be collected from the medical records (paper/electronic) of each patient at several outpatient clinics to describe the two periods of medical history: before and after the initiation date of Tresiba®. For each patient, data will be collected, to describe a minimum of 6 months to a maximum of 12 months in each period; thus, the study will collect information on 12 to 24 months of medical history for each patient.
Study Groups/Cohorts Tresiba®
Intervention: Other: No treatment given
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 28, 2016)
2302
Original Estimated Enrollment
 (submitted: January 21, 2016)
2644
Actual Study Completion Date August 12, 2016
Actual Primary Completion Date August 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient
  • Age at least 18 years at the time of Tresiba® initiation
  • T1DM or insulin-treated T2DM patients
  • Switched to Tresiba® (with or without prandial insulin) after any basal insulin (with or without prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with Tresiba® at the time of patient selection
  • Previously treated with any basal insulin (with or without prandial insulin) for at least 6 months prior to switching to Tresiba®
  • At least one documented medical visit in the first 9 months after Tresiba® initiation
  • Minimum available data at the time of Tresiba® initiation: age, type of diabetes, HbA1c (Glycated haemoglobin), duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site of at least 1 year, and an eGFR (Estimated glomerular filtration rate )value in the last 12 months

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having signed the Informed Consent
  • Participation in a diabetes clinical trial or receipt of any investigational medicinal product up to 12 months before or any time after the initiation of Tresiba®
  • Current participation in another non-interventional study on insulin degludec (Tresiba®)
  • Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba®
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Denmark,   Germany,   Greece,   Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02662114
Other Study ID Numbers NN1250-4240
U1111-1170-3128 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date April 2019