Diabetes Mellitus, Type 1CAN-TREATNCT03674866

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

An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 32 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What is being tested?: Insulin degludec
How many people: 662 participants
Where: 32 sitesCanada
Study dates: 29 Oct 2018to 26 Apr 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

Canada32 sites

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

Other trials in Canada

About this study

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)

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.

Conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Being tested: Insulin degludec
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03674866
Study group	Role	What they receive
Patients with diabetes		Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®). Receives: Drug: Insulin degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glycated Haemoglobin (HbA1c)
measured in % point
Measured: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

Secondary outcomes (16)

Change in percentage of patients with HbA1c below 7%
percentage of patients
Measured: 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%
percentage of patients
Measured: 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%
percentage of patients
Measured: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in the mean Fasting Plasma Glucose (FPG)
measured in mmol/L
Measured: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Insulin degludec dose
measured in units/day
Measured: At switch to insulin degludec (week 0)
Insulin degludec dose
measured in units/day
Measured: 6 months after switch to insulin degludec
Change in the mean daily insulin doses (total, basal, prandial)
measured in units/day
Measured: 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
number of concomitant non-insulin glucose-lowering drug classes
Measured: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in body weight
measured in kg
Measured: 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)
percentage of patients
Measured: 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)
percentage of patients
Measured: After change to insulin degludec (0 to 6 months)
Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
rates of hypoglycaemic episodes
Measured: Before change to insulin degludec (-6 to 0 months)
Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
rates of hypoglycaemic episodes
Measured: After change to insulin degludec (0 to 6 months)
Percentage of patients continuing insulin degludec
percentage of patients
Measured: After change to insulin degludec (0 to 6 months)
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
Measured: At time of switch to insulin degludec (week 0)
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
Measured: At time of discontinuing insulin degludec (0 to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201826 Apr 2019

First posted18 Sep 2018
Study start29 Oct 2018
Primary completion25 Apr 2019
Study completion26 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 662 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03674866
Sponsor's protocol ID: NN1250-4396
Other IDs: U1111-1203-7872
Acronym: CAN-TREAT
Status last verified: Dec 2019
First submitted: 5 Sep 2018
Last updated: 6 Dec 2019
Results posted: No
Data monitoring committee: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

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.
PubMed 33932223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03674866
Acronym / sponsor ID: CAN-TREAT / NN1250-4396
Conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 662 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 29 Oct 2018 (actual)
Primary completion: 25 Apr 2019 (actual)
Study completion: 26 Apr 2019 (actual)
First posted: 18 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients with diabetes	–	Drug: Insulin degludecPatients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with type 1 or type 2 diabetes mellitus whose basal insulin was switched to insulin degludec

Key inclusion criteria (7 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin degludecParticipants are treated with Tresiba® (insulin degludec) under conditions of routine care.	Drug	Patients with diabetes

Primary outcome

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

16 secondary outcomes

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
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
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
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
Insulin degludec dose
Time frame: At switch to insulin degludec (week 0)
Insulin degludec dose
Time frame: 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
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
Change in body weight
Time frame: 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)
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)
Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)
Time frame: 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)
Percentage of patients continuing insulin degludec
Time frame: 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)
Reason(s) for discontinuing insulin degludec
Time frame: At time of discontinuing insulin degludec (0 to 6 months)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
Derived from this study: PubMed 33932223Harris 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.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Reporting Anchor and Disclosure (1452) study director

Novo Nordisk A/S

32 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 32 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03674866, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.