Clinical trial NCT03674866: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 662
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 or type 2 diabetes mellitus whose basal insulin was switched to insulin degludec

Brief 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 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
* 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

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary outcomes:
measure: Change in percentage of patients with HbA1c below 7%
timeFrame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measure: Change in percentage of patients with HbA1c below 7.5%
timeFrame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measure: Change in percentage of patients with HbA1c below 8.0%
timeFrame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measure: Change in the mean Fasting Plasma Glucose (FPG)
timeFrame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measure: Insulin degludec dose
timeFrame: At switch to insulin degludec (week 0)
measure: Insulin degludec dose
timeFrame: 6 months after switch to insulin degludec
measure: Change in the mean daily insulin doses (total, basal, prandial)
timeFrame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measure: Change in the number of concomitant non-insulin glucose-lowering drug classes
timeFrame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measure: Change in body weight
timeFrame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
measure: Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)
timeFrame: Before change to insulin degludec (-6 to 0 months)
measure: Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)
timeFrame: After change to insulin degludec (0 to 6 months)
measure: Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
timeFrame: Before change to insulin degludec (-6 to 0 months)
measure: Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
timeFrame: After change to insulin degludec (0 to 6 months)
measure: Percentage of patients continuing insulin degludec
timeFrame: After change to insulin degludec (0 to 6 months)
measure: Reason(s) for starting insulin degludec
timeFrame: At time of switch to insulin degludec (week 0)
measure: Reason(s) for discontinuing insulin degludec
timeFrame: At time of discontinuing insulin degludec (0 to 6 months)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Shubenacadie
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Sydney
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Ajax
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Cambridge
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Concord
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Guelph
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Nepean
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Orillia
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Smiths Falls
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Tecumseh
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Gatineau
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Pierrefonds
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Terrebonne
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Harris SB, Ajala O, Bari B, Liutkus J, Hahn J, Martyn O, Zwicker D. Evaluating the Effectiveness of Switching to Insulin Degludec from Other Basal Insulins in a Real-World Canadian Population with Type 1 or Type 2 Diabetes: The CAN-TREAT Study. Diabetes Ther. 2021 Jun;12(6):1689-1702. doi: 10.1007/s13300-021-01063-5. Epub 2021 May 1.