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

Diabetes Mellitus, Type 2 Clinical Trial

— CAN-TREAT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674866
• Other study ID #: NN1250-4396
• Secondary ID: U1111-1203-7872
• Status: Completed
• Start date: October 29, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: December 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: April 26, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin degludec
Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Ajax	Ontario
Canada	Novo Nordisk Investigational Site	Brampton	Ontario
Canada	Novo Nordisk Investigational Site	Calgary	Alberta
Canada	Novo Nordisk Investigational Site	Cambridge	Ontario
Canada	Novo Nordisk Investigational Site	Concord	Ontario
Canada	Novo Nordisk Investigational Site	Edmonton	Alberta
Canada	Novo Nordisk Investigational Site	Etobicoke	Ontario
Canada	Novo Nordisk Investigational Site	Gatineau	Quebec
Canada	Novo Nordisk Investigational Site	Guelph	Ontario
Canada	Novo Nordisk Investigational Site	Halifax	Nova Scotia
Canada	Novo Nordisk Investigational Site	Laval	Quebec
Canada	Novo Nordisk Investigational Site	London	Ontario
Canada	Novo Nordisk Investigational Site	London	Ontario
Canada	Novo Nordisk Investigational Site	Markham	Ontario
Canada	Novo Nordisk Investigational Site	Markham	Ontario
Canada	Novo Nordisk Investigational Site	Montreal	Quebec
Canada	Novo Nordisk Investigational Site	Montreal	Quebec
Canada	Novo Nordisk Investigational Site	Montreal	Quebec
Canada	Novo Nordisk Investigational Site	Montreal	Quebec
Canada	Novo Nordisk Investigational Site	Nepean	Ontario
Canada	Novo Nordisk Investigational Site	Oakville	Ontario
Canada	Novo Nordisk Investigational Site	Orillia	Ontario
Canada	Novo Nordisk Investigational Site	Pierrefonds	Quebec
Canada	Novo Nordisk Investigational Site	Scarborough	Ontario
Canada	Novo Nordisk Investigational Site	Shubenacadie	Nova Scotia
Canada	Novo Nordisk Investigational Site	Smiths Falls	Ontario
Canada	Novo Nordisk Investigational Site	Sydney	Nova Scotia
Canada	Novo Nordisk Investigational Site	Tecumseh	Ontario
Canada	Novo Nordisk Investigational Site	Terrebonne	Quebec
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Canada	Novo Nordisk Investigational Site	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Haemoglobin (HbA1c)	measured in % point	Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary	Change in percentage of patients with HbA1c below 7%	percentage of patients	Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary	Change in percentage of patients with HbA1c below 7.5%	percentage of patients	Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary	Change in percentage of patients with HbA1c below 8.0%	percentage of patients	Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary	Change in the mean Fasting Plasma Glucose (FPG)	measured in mmol/L	Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary	Insulin degludec dose	measured in units/day	At switch to insulin degludec (week 0)
Secondary	Insulin degludec dose	measured in units/day	6 months after switch to insulin degludec
Secondary	Change in the mean daily insulin doses (total, basal, prandial)	measured in units/day	Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary	Change in the number of concomitant non-insulin glucose-lowering drug classes	number of concomitant non-insulin glucose-lowering drug classes	Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary	Change in body weight	measured in kg	Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Secondary	Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)	percentage of patients	Before change to insulin degludec (-6 to 0 months)
Secondary	Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)	percentage of patients	After change to insulin degludec (0 to 6 months)
Secondary	Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)	rates of hypoglycaemic episodes	Before change to insulin degludec (-6 to 0 months)
Secondary	Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)	rates of hypoglycaemic episodes	After change to insulin degludec (0 to 6 months)
Secondary	Percentage of patients continuing insulin degludec	percentage of patients	After change to insulin degludec (0 to 6 months)
Secondary	Reason(s) for starting insulin degludec	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)
Secondary	Reason(s) for discontinuing insulin degludec	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)