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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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