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

NCT03457012 | Completed

• 2 other identifiers: NN9535-4428U1111-1205-5853
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Change in Glycated Haemoglobin A1c (HbA1c)

  Measured in % points

  Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)

• Change in HbA1c

  Measured in mmol/mol

  Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)

Secondary Outcomes (16)

• Change in body weight

  Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)

• Change in body weight

  Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38)

• Change in waist circumference

  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)

  At end of study (week 28-38)

• HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no)

  At end of study (week 28-38)

Study Arms (1)

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

Interventions

Semaglutide DRUG

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.

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with type 2 diabetes

You may qualify if:

• 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
• Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of semaglutide treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Cambridge, Ontario, N1R 7L6, Canada

Location

Related Publications (2)

• 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.

  PMID: 34142429 RESULT

• 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.

  PMID: 35383100 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: March 29, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)