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

December 5, 2019 updated by: Novo Nordisk A/S

A Canadian 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 CAN-TREAT (CANadian TREsiba AudiT)

The purpose of this study is to collect historical data in real life conditions in a large group of people who have type 1 or type 2 diabetes and were treated with Tresiba® (insulin degludec) for at least 6 months. Data will be collected beginning 6 months before the participant started Tresiba® up to around 6 months after the participant started taking insulin degludec.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

662

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • Novo Nordisk Investigational Site
      • Edmonton, Alberta, Canada, T5T 3J7
        • Novo Nordisk Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6J 4Y3
        • Novo Nordisk Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Novo Nordisk Investigational Site
      • Shubenacadie, Nova Scotia, Canada, B2T 1A4
        • Novo Nordisk Investigational Site
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Novo Nordisk Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • Novo Nordisk Investigational Site
      • Brampton, Ontario, Canada, L6S 0C6
        • Novo Nordisk Investigational Site
      • Cambridge, Ontario, Canada, N1R 7L6
        • Novo Nordisk Investigational Site
      • Concord, Ontario, Canada, L4K 4M2
        • Novo Nordisk Investigational Site
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Novo Nordisk Investigational Site
      • Guelph, Ontario, Canada, N1H 3R3
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6G 2M1
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6A 4V2
        • Novo Nordisk Investigational Site
      • Markham, Ontario, Canada, L3P 7P2
        • Novo Nordisk Investigational Site
      • Markham, Ontario, Canada, L3S 0A2
        • Novo Nordisk Investigational Site
      • Nepean, Ontario, Canada, K2J 0V2
        • Novo Nordisk Investigational Site
      • Oakville, Ontario, Canada, L6M 1M1
        • Novo Nordisk Investigational Site
      • Orillia, Ontario, Canada, L3V 2Z6
        • Novo Nordisk Investigational Site
      • Scarborough, Ontario, Canada, M1E 5E9
        • Novo Nordisk Investigational Site
      • Smiths Falls, Ontario, Canada, K7A 4W8
        • Novo Nordisk Investigational Site
      • Tecumseh, Ontario, Canada, N8N 4M7
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M6G 1M2
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Novo Nordisk Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 0A7
        • Novo Nordisk Investigational Site
      • Laval, Quebec, Canada, H7T 2P5
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H4T 1Z9
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H4A 2C6
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H4A 3T2
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H2K 1H2
        • Novo Nordisk Investigational Site
      • Pierrefonds, Quebec, Canada, H8Z 1W5
        • Novo Nordisk Investigational Site
      • Terrebonne, Quebec, Canada, J6X 4P7
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 1 or type 2 diabetes mellitus whose basal insulin was switched to insulin degludec

Description

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
  • Male or female age greater than or equal to 18 years at the time of insulin degludec initiation
  • Type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus patients
  • Switched to insulin degludec (± prandial insulin) after any basal insulin (± prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with insulin degludec at the time of patient selection
  • Previously treated with any basal insulin (± prandial insulin) for at least 6 months prior to switching to insulin degludec
  • At least one documented medical visit in the first 6 months (closest value in 3 to 9 months window) after insulin degludec initiation
  • Minimum available data at the time of insulin degludec initiation: age, type of diabetes, HbA1c, duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site for at least 1 year, and an estimated glomerular filtration rate (eGFR) value in the last 12 ±6 months (full data period)

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having signed the Informed Consent in this study
  • Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with diabetes
Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®).
Drug: Insulin degludec
Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measured in % point
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage of patients with HbA1c below 7%
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
percentage of patients
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in percentage of patients with HbA1c below 7.5%
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
percentage of patients
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in percentage of patients with HbA1c below 8.0%
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
percentage of patients
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in the mean Fasting Plasma Glucose (FPG)
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measured in mmol/L
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Insulin degludec dose
Time Frame: At switch to insulin degludec (week 0)
measured in units/day
At switch to insulin degludec (week 0)
Insulin degludec dose
Time Frame: 6 months after switch to insulin degludec
measured in units/day
6 months after switch to insulin degludec
Change in the mean daily insulin doses (total, basal, prandial)
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measured in units/day
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in the number of concomitant non-insulin glucose-lowering drug classes
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
number of concomitant non-insulin glucose-lowering drug classes
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in body weight
Time Frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measured in kg
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)
Time Frame: Before change to insulin degludec (-6 to 0 months)
percentage of patients
Before change to insulin degludec (-6 to 0 months)
Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)
Time Frame: After change to insulin degludec (0 to 6 months)
percentage of patients
After change to insulin degludec (0 to 6 months)
Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
Time Frame: Before change to insulin degludec (-6 to 0 months)
rates of hypoglycaemic episodes
Before change to insulin degludec (-6 to 0 months)
Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
Time Frame: After change to insulin degludec (0 to 6 months)
rates of hypoglycaemic episodes
After change to insulin degludec (0 to 6 months)
Percentage of patients continuing insulin degludec
Time Frame: After change to insulin degludec (0 to 6 months)
percentage of patients
After change to insulin degludec (0 to 6 months)
Reason(s) for starting insulin degludec
Time Frame: At time of switch to insulin degludec (week 0)
Reasons for starting insulin degludec (if available) will be classified as: Not at glycaemic target, Hypoglycaemia (severe / non-severe / nocturnal), Hypoglycaemia unawareness, Multiple risk factors for hypoglycaemia (elderly, intensive exercise, Chronic Kidney Disease, other), Basal insulin dose more than 80 units/day, Twice daily basal insulin dosing, Fasting blood glucose variability, Need for flexible time of dosing, Device issue, other
At time of switch to insulin degludec (week 0)
Reason(s) for discontinuing insulin degludec
Time Frame: At time of discontinuing insulin degludec (0 to 6 months)
Reasons for discontinuing insulin degludec (if applicable and available) will be classified as: Injection site reaction, Insufficient efficacy, Hypoglycaemia (severe / non-severe / nocturnal), Weight gain, Cost, Device issue, Other
At time of discontinuing insulin degludec (0 to 6 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

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)

October 29, 2018

Primary Completion (Actual)

April 25, 2019

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-4396
  • U1111-1203-7872 (Other Identifier: World Health Organization (WHO))

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 device product

No

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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