A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Canada, as Part of Local Clinical Practice (SURE CANADA)

August 31, 2021 updated by: Novo Nordisk A/S

SURE CANADA: A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Once Weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about the health and the diabetes treatment. Participants will complete these during the normally scheduled visits with the study doctor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
462

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7L6
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with type 2 diabetes

Description

Inclusion Criteria:

  • Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
  • The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
  • Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of semaglutide treatment

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Treatment with any investigational drug within 90 days prior to enrolment into the study
  • Hypersensitivity to semaglutide or to any of the excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Semaglutide
Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks
Drug: Semaglutide
Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Glycated Haemoglobin A1c (HbA1c)
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Measured in % points
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Change in HbA1c
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Measured in mmol/mol
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Measured in kg
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Change in body weight
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Measured in %
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Change in waist circumference
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Measured in cm
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
HbA1c level at end of study: < 8.0% (64 mmol/mol) (yes/no)
Time Frame: At end of study (week 28-38)
Number of participants who achieved/not achieved HbA1c level at end of study: <8.0%
At end of study (week 28-38)
HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no)
Time Frame: At end of study (week 28-38)
Number of participants who achieved/not achieved HbA1c level at end of study: <7.5%
At end of study (week 28-38)
HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no)
Time Frame: At end of study (week 28-38)
Number of participants who achieved/not achieved HbA1c level at end of study: <7.0%
At end of study (week 28-38)
Reduction in HbA1c of 1.0% point or more (yes/no)
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Weight reduction of 3.0% or more (yes/no)
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Number of participants who achieved/not achieved weight reduction of 3.0% or more
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Weight reduction of 5.0% or more (yes/no)
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Number of participants who achieved/not achieved weight reduction of 5.0% or more
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)
Time Frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Patient reported severe or documented hypoglycaemia (yes/no)
Time Frame: Between baseline (week 0) and end of study (week 28-38)
Number of participants who reported/not reported severe or documented hypogycaemia
Between baseline (week 0) and end of study (week 28-38)
Change in Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction
Time Frame: Baseline (week 0), end of study (week 28-38)
The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively.
Baseline (week 0), end of study (week 28-38)
Change in Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction
Time Frame: Baseline (week 0), end of study (week 28-38)
The change version (DTSQc) has the same 8 items as the status version, but is reworded to direct the patients to compare the experience of the current treatment with the experience of previous treatment. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change.
Baseline (week 0), end of study (week 28-38)
Change in Short Form (SF)-36 v2: Physical summary component
Time Frame: Baseline (week 0), end of study (week 28-38)
The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health).
Baseline (week 0), end of study (week 28-38)
Change in SF-36 v2: Mental summary component
Time Frame: Baseline (week 0), end of study (week 28-38)
The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health).
Baseline (week 0), end of study (week 28-38)
Patient completed the study under treatment with semaglutide (yes/no)
Time Frame: At end of study (week 28-38)
Number of patients who completed/not completed the study under treatment with semaglutide
At end of study (week 28-38)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9535-4428
  • U1111-1205-5853 (Other Identifier: World Health Organisation (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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