Clinical trial NCT04083820: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in France, as Part of Local Clinical Practice (SURE FRANCE)
Official title: 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: 2019-09-10
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 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.


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 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

Primary outcomes:
measure: Change in Glycated Haemoglobin A1c (HbA1c)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
measure: Change in Glycated Haemoglobin A1c (HbA1c)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
measure: Change in body weight
timeFrame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
measure: Change in waist circumference
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: HbA1c level below 8.0% (64 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level below 7.5% (59 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level below 7.0% (53 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 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 to 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 to 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 to 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 to 38)
measure: Patient reported severe or documented hypoglycaemia (yes/no)
timeFrame: Between baseline (week 0), end of study (week 28-38)
measure: Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Change in score for Short Form (SF)-36 v2: Physical summary component
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Change in score for SF-36 v2: Mental summary component
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Patient completed the study under treatment with semaglutide (yes/no)
timeFrame: At end of study (week 28 to 38)
Other outcomes:
Locations:
city: Angers
country: France
facility: Novo Nordisk Investigational Site
city: Annecy
country: France
facility: Novo Nordisk Investigational Site
city: Auffay
country: France
facility: Novo Nordisk Investigational Site
city: Avignon
country: France
facility: Novo Nordisk Investigational Site
city: Besançon
country: France
facility: Novo Nordisk Investigational Site
city: Bethoncourt
country: France
facility: Novo Nordisk Investigational Site
city: Beze
country: France
facility: Novo Nordisk Investigational Site
city: Bourgoin-jallieu
country: France
facility: Novo Nordisk Investigational Site
city: Bry sur Marne
country: France
facility: Novo Nordisk Investigational Site
city: Caen
country: France
facility: Novo Nordisk Investigational Site
city: Challes les Eaux
country: France
facility: Novo Nordisk Investigational Site
city: Chalon sur Saone
country: France
facility: Novo Nordisk Investigational Site
city: Chalons Sur Saone
country: France
facility: Novo Nordisk Investigational Site
city: Charleville-Mézières
country: France
facility: Novo Nordisk Investigational Site
city: Chelles
country: France
facility: Novo Nordisk Investigational Site
city: Clichy
country: France
facility: Novo Nordisk Investigational Site
city: Colmar
country: France
facility: Novo Nordisk Investigational Site
city: Colmar
country: France
facility: Novo Nordisk Investigational Site
city: DIJON cedex
country: France
facility: Novo Nordisk Investigational Site
city: Dijon
country: France
facility: Novo Nordisk Investigational Site
city: Dole
country: France
facility: Novo Nordisk Investigational Site
city: Doudeville
country: France
facility: Novo Nordisk Investigational Site
city: Elancourt
country: France
facility: Novo Nordisk Investigational Site
city: Guiscard
country: France
facility: Novo Nordisk Investigational Site
city: La Bouëxière
country: France
facility: Novo Nordisk Investigational Site
city: La Madeleine
country: France
facility: Novo Nordisk Investigational Site
city: Lambersart
country: France
facility: Novo Nordisk Investigational Site
city: Le Puy en Velay
country: France
facility: Novo Nordisk Investigational Site
city: Lomme
country: France
facility: Novo Nordisk Investigational Site
city: Lyon
country: France
facility: Novo Nordisk Investigational Site
city: Maison-Alfort
country: France
facility: Novo Nordisk Investigational Site
city: Marseille
country: France
facility: Novo Nordisk Investigational Site
city: MONTPELLIER cedex 5
country: France
facility: Novo Nordisk Investigational Site
city: Montélimar
country: France
facility: Novo Nordisk Investigational Site
city: Nevers
country: France
facility: Novo Nordisk Investigational Site
city: NICE cedex 3
country: France
facility: Novo Nordisk Investigational Site
city: Noisy le Grand
country: France
facility: Novo Nordisk Investigational Site
city: Orry-la-ville
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Pessac
country: France
facility: Novo Nordisk Investigational Site
city: Pierre-Bénite
country: France
facility: Novo Nordisk Investigational Site
city: Six Fours les plages
country: France
facility: Novo Nordisk Investigational Site
city: Ste Foy Lès Lyon
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: Toulouse
country: France
facility: Novo Nordisk Investigational Site
city: Tours
country: France
facility: Novo Nordisk Investigational Site
city: Valence
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Vichy
country: France
facility: Novo Nordisk Investigational Site
city: Vienne
country: France
facility: Novo Nordisk Investigational Site
city: Vitré
country: France
facility: Novo Nordisk Investigational Site
city: Yerres
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: 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.