MedDataX Logo

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

NCT ID: NCT03674866

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

662 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-29

Study Completion Date

2019-04-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with diabetes

Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®).

Insulin degludec

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Insulin degludec

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Calgary, Alberta, Canada

Site Status

Novo Nordisk Investigational Site

Edmonton, Alberta, Canada

Site Status

Novo Nordisk Investigational Site

Vancouver, British Columbia, Canada

Site Status

Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada

Site Status

Novo Nordisk Investigational Site

Shubenacadie, Nova Scotia, Canada

Site Status

Novo Nordisk Investigational Site

Sydney, Nova Scotia, Canada

Site Status

Novo Nordisk Investigational Site

Ajax, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Brampton, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Cambridge, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Concord, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Etobicoke, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Guelph, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

London, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

London, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Markham, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Markham, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Nepean, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Oakville, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Orillia, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Scarborough Village, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Smiths Falls, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Tecumseh, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Gatineau, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Laval, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Pierrefonds, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Terrebonne, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33932223 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1203-7872

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-4396

Identifier Type: -

Identifier Source: org_study_id