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

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ClinicalTrials.gov Identifier: NCT03457012
Recruitment Status : Enrolling by invitation
First Posted : March 7, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Semaglutide

Study Type : Observational
Estimated Enrollment : 217 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : November 25, 2019
Estimated Study Completion Date : November 25, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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 %

  3. 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

  4. 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%

  5. 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%

  6. 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%

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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).

  15. 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).

  16. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants with type 2 diabetes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457012


Locations
Canada, Ontario
Novo Nordisk Investigational Site
Cambridge, Ontario, Canada, N1R 7L6
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03457012     History of Changes
Other Study ID Numbers: NN9535-4428
U1111-1205-5853 ( Other Identifier: World Health Organisation (WHO) )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://www.novonordisk-trials.com

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases