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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

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)

NCT03674866•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

Locations (32)

Novo Nordisk Investigational Site

Calgary, Alberta, Canada

Novo Nordisk Investigational Site

Edmonton, Alberta, Canada

Novo Nordisk Investigational Site

Vancouver, British Columbia, Canada

Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada

Novo Nordisk Investigational Site

Shubenacadie, Nova Scotia, Canada

Novo Nordisk Investigational Site

Sydney, Nova Scotia, Canada

Novo Nordisk Investigational Site

Ajax, Ontario, Canada

Novo Nordisk Investigational Site

Brampton, Ontario, Canada

Novo Nordisk Investigational Site

Cambridge, Ontario, Canada

Novo Nordisk Investigational Site

Concord, Ontario, Canada

Key Dates

Start Date

October 29, 2018

Primary Completion Date

April 25, 2019

Completion Date

April 26, 2019

Last Updated

December 6, 2019

Enrollment

662

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin degludec

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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