Clinical trial NCT03457012: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Canada, as Part of Local Clinical Practice
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes

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.


Eligibility 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

Primary outcomes:
measure: Change in Glycated Haemoglobin A1c (HbA1c)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
measure: Change in HbA1c
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
measure: Change in body weight
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
measure: Change in waist circumference
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
measure: HbA1c level at end of study: < 8.0% (64 mmol/mol) (yes/no)
timeFrame: At end of study (week 28-38)
measure: HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no)
timeFrame: At end of study (week 28-38)
measure: HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no)
timeFrame: At end of study (week 28-38)
measure: Reduction in HbA1c of 1.0% point or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
measure: Weight reduction of 3.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
measure: Weight reduction of 5.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
measure: HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)
measure: Patient reported severe or documented hypoglycaemia (yes/no)
timeFrame: Between baseline (week 0) and end of study (week 28-38)
measure: Change in Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction
timeFrame: Baseline (week 0), end of study (week 28-38)
measure: Change in Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction
timeFrame: Baseline (week 0), end of study (week 28-38)
measure: Change in Short Form (SF)-36 v2: Physical summary component
timeFrame: Baseline (week 0), end of study (week 28-38)
measure: Change in SF-36 v2: Mental summary component
timeFrame: Baseline (week 0), end of study (week 28-38)
measure: Patient completed the study under treatment with semaglutide (yes/no)
timeFrame: At end of study (week 28-38)
Other outcomes:
Locations:
city: Cambridge
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Yale JF, Catarig AM, Grau K, Harris S, Klimek-Abercrombie A, Rabasa-Lhoret R, Reardon L, Woo V, Liutkus J. Use of once-weekly semaglutide in patients with type 2 diabetes in routine clinical practice: Results from the SURE Canada multicentre, prospective, observational study. Diabetes Obes Metab. 2021 Oct;23(10):2269-2278. doi: 10.1111/dom.14468. Epub 2021 Aug 15.
citation: Yale JF, Bodholdt U, Catarig AM, Catrina S, Clark A, Ekberg NR, Erhan U, Holmes P, Knudsen ST, Liutkus J, Sathyapalan T, Schultes B, Rudofsky G. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: pooled analysis of data from four SURE studies by baseline characteristic subgroups. BMJ Open Diabetes Res Care. 2022 Apr;10(2):e002619. doi: 10.1136/bmjdrc-2021-002619.