NCT03674866|Completed

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

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)

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN1250-4396U1111-1203-7872

Study Type

observational

Target

662

Locations

1 country

Sites

Timeline

RegisteredSep 2018

StartedOct 2018

CompletionApr 2019

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

662

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach

1 country

32 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

September 5, 2018

Completed

13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed

1 month until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed

Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

September 5, 2018

Last Update Submit

December 5, 2019

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycated Haemoglobin (HbA1c)
measured in % point
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%
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%
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%
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Change in the mean Fasting Plasma Glucose (FPG)
Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec
Insulin degludec dose
At switch to insulin degludec (week 0)
+11 more secondary outcomes

Study Arms (1)

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

Interventions

Insulin degludecDRUG

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

Patients with diabetes

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.