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

NCT ID: NCT04083820

Last Updated: 2023-03-28

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

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Recruitment Status

COMPLETED

Total Enrollment

521 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-16

Study Completion Date

2021-09-27

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Semaglutide s.c. once-weekly

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.

semaglutide

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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 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 haemoglobin A1c (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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Angers, , France

Site Status

Novo Nordisk Investigational Site

Annecy, , France

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Novo Nordisk Investigational Site

Auffay, , France

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Novo Nordisk Investigational Site

Avignon, , France

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Novo Nordisk Investigational Site

Besançon, , France

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Novo Nordisk Investigational Site

Bethoncourt, , France

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Novo Nordisk Investigational Site

Bèze, , France

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Novo Nordisk Investigational Site

Bourgoin, , France

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Novo Nordisk Investigational Site

Bry-sur-Marne, , France

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Novo Nordisk Investigational Site

Caen, , France

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Novo Nordisk Investigational Site

Challes-les-Eaux, , France

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Novo Nordisk Investigational Site

Chalon-sur-Saône, , France

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Novo Nordisk Investigational Site

Charleville-Mézières, , France

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Novo Nordisk Investigational Site

Chelles, , France

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Novo Nordisk Investigational Site

Clichy, , France

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Novo Nordisk Investigational Site

Colmar, , France

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Colmar, , France

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Dijon, , France

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Dijon, , France

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Novo Nordisk Investigational Site

Dole, , France

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Novo Nordisk Investigational Site

Doudeville, , France

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Novo Nordisk Investigational Site

Élancourt, , France

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Novo Nordisk Investigational Site

Guiscard, , France

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Novo Nordisk Investigational Site

La Bouëxière, , France

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Novo Nordisk Investigational Site

La Madeleine, , France

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Novo Nordisk Investigational Site

Lambersart, , France

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Novo Nordisk Investigational Site

Le Puy-en-Velay, , France

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Novo Nordisk Investigational Site

Lomme, , France

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Novo Nordisk Investigational Site

Lyon, , France

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Novo Nordisk Investigational Site

Maison-Alfort, , France

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Novo Nordisk Investigational Site

Marseille, , France

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Novo Nordisk Investigational Site

Montélimar, , France

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Novo Nordisk Investigational Site

Montpellier, , France

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Novo Nordisk Investigational Site

Nevers, , France

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Novo Nordisk Investigational Site

Nice, , France

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Novo Nordisk Investigational Site

Noisy-le-Grand, , France

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Novo Nordisk Investigational Site

Orry-la-Ville, , France

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Novo Nordisk Investigational Site

Paris, , France

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Novo Nordisk Investigational Site

Paris, , France

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Novo Nordisk Investigational Site

Paris, , France

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Novo Nordisk Investigational Site

Pessac, , France

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Novo Nordisk Investigational Site

Pierre-Bénite, , France

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Novo Nordisk Investigational Site

Six-Fours-les-Plages, , France

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Novo Nordisk Investigational Site

Ste Foy Lès Lyon, , France

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Novo Nordisk Investigational Site

Strasbourg, , France

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Novo Nordisk Investigational Site

Toulouse, , France

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Novo Nordisk Investigational Site

Tours, , France

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Novo Nordisk Investigational Site

Valence, , France

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Novo Nordisk Investigational Site

Vénissieux, , France

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Novo Nordisk Investigational Site

Vichy, , France

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Novo Nordisk Investigational Site

Vienne, , France

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Novo Nordisk Investigational Site

Vitré, , France

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Novo Nordisk Investigational Site

Yerres, , France

Site Status

Countries

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France

References

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Mohammedi K, Belhatem N, Berentzen TL, Catarig AM, Potier L. Once-weekly semaglutide use in patients with type 2 diabetes: Results from the SURE France multicentre, prospective, observational study. Diabetes Obes Metab. 2023 Jul;25(7):1855-1864. doi: 10.1111/dom.15045. Epub 2023 Mar 28.

Reference Type BACKGROUND
PMID: 36869853 (View on PubMed)

Other Identifiers

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U1111-1222-5620

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4495

Identifier Type: -

Identifier Source: org_study_id

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