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

A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: semaglutide

• Study Type: Observational
• Enrollment (Actual): 521

Contacts and Locations

Study Locations

• France
  • Angers, France, 37540
    • Novo Nordisk Investigational Site
  • Annecy, France, 74600
    • Novo Nordisk Investigational Site
  • Auffay, France, 76720
    • Novo Nordisk Investigational Site
  • Avignon, France, 84902
    • Novo Nordisk Investigational Site
  • Besançon, France, 25000
    • Novo Nordisk Investigational Site
  • Bethoncourt, France, 25200
    • Novo Nordisk Investigational Site
  • Beze, France, 21310
    • Novo Nordisk Investigational Site
  • Bourgoin-jallieu, France, 38302
    • Novo Nordisk Investigational Site
  • Bry sur Marne, France, 94360
    • Novo Nordisk Investigational Site
  • Caen, France, 14033
    • Novo Nordisk Investigational Site
  • Challes les Eaux, France, 73190
    • Novo Nordisk Investigational Site
  • Chalon sur Saone, France, 71100
    • Novo Nordisk Investigational Site
  • Chalons Sur Saone, France, 71100
    • Novo Nordisk Investigational Site
  • Charleville-Mézières, France, 08000
    • Novo Nordisk Investigational Site
  • Chelles, France, 77500
    • Novo Nordisk Investigational Site
  • Clichy, France, 92110
    • Novo Nordisk Investigational Site
  • Colmar, France, 68000
    • Novo Nordisk Investigational Site
  • Colmar, France, 68024
    • Novo Nordisk Investigational Site
  • DIJON cedex, France, 21079
    • Novo Nordisk Investigational Site
  • Dijon, France, 21000
    • Novo Nordisk Investigational Site
  • Dole, France, 39100
    • Novo Nordisk Investigational Site
  • Doudeville, France, 76560
    • Novo Nordisk Investigational Site
  • Elancourt, France, 78990
    • Novo Nordisk Investigational Site
  • Guiscard, France, 60640
    • Novo Nordisk Investigational Site
  • La Bouëxière, France, 35340
    • Novo Nordisk Investigational Site
  • La Madeleine, France, 59110
    • Novo Nordisk Investigational Site
  • Lambersart, France, 59130
    • Novo Nordisk Investigational Site
  • Le Puy en Velay, France, 43000
    • Novo Nordisk Investigational Site
  • Lomme, France, 59462
    • Novo Nordisk Investigational Site
  • Lyon, France, 69007
    • Novo Nordisk Investigational Site
  • MONTPELLIER cedex 5, France, 34295
    • Novo Nordisk Investigational Site
  • Maison-Alfort, France, 94700
    • Novo Nordisk Investigational Site
  • Marseille, France, 13006
    • Novo Nordisk Investigational Site
  • Montélimar, France, 26200
    • Novo Nordisk Investigational Site
  • NICE cedex 3, France, 06202
    • Novo Nordisk Investigational Site
  • Nevers, France, 58000
    • Novo Nordisk Investigational Site
  • Noisy le Grand, France, 93160
    • Novo Nordisk Investigational Site
  • Orry-la-ville, France, 60560
    • Novo Nordisk Investigational Site
  • Paris, France, 75010
    • Novo Nordisk Investigational Site
  • Paris, France, 75877
    • Novo Nordisk Investigational Site
  • Paris, France, 75014
    • Novo Nordisk Investigational Site
  • Pessac, France, 33600
    • Novo Nordisk Investigational Site
  • Pierre-Bénite, France, 69495
    • Novo Nordisk Investigational Site
  • Six Fours les plages, France, 83140
    • Novo Nordisk Investigational Site
  • Ste Foy Lès Lyon, France, 69110
    • Novo Nordisk Investigational Site
  • Strasbourg, France, 67000
    • Novo Nordisk Investigational Site
  • Toulouse, France, 31300
    • Novo Nordisk Investigational Site
  • Tours, France, 37000
    • Novo Nordisk Investigational Site
  • Valence, France, 26000
    • Novo Nordisk Investigational Site
  • Venissieux, France, 69200
    • Novo Nordisk Investigational Site
  • Vichy, France, 03207
    • Novo Nordisk Investigational Site
  • Vienne, France, 38500
    • Novo Nordisk Investigational Site
  • Vitré, France, 35500
    • Novo Nordisk Investigational Site
  • Yerres, France, 91330
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with type 2 diabetes

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin A1c (HbA1c)	Measured in % point	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in Glycated Haemoglobin A1c (HbA1c)	Measured in mmol/mol	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Measured in kg	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in body weight	Measured in %	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in waist circumference	Measured in cm	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
HbA1c level below 8.0% (64 mmol/mol) (yes/no)	Number of participants	At end of study (week 28 to 38)
Reduction in HbA1c of 1.0% point or more (yes/no)	Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Weight reduction of 3.0% or more (yes/no)	Number of participants who achieved/not achieved weight reduction of 3.0% or more	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Weight reduction of 5.0% or more (yes/no)	Number of participants who achieved/not achieved weight reduction of 5.0% or more	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)	Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction	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	Baseline (week 0), end of study (week 28 to 38)
Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction	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	Baseline (week 0), end of study (week 28 to 38)
Change in score for Short Form (SF)-36 v2: Physical summary component	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).	Baseline (week 0), end of study (week 28 to 38)
Change in score for SF-36 v2: Mental summary component	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).	Baseline (week 0), end of study (week 28 to 38)
HbA1c level below 7.5% (59 mmol/mol) (yes/no)	Number of participants	At end of study (week 28 to 38)
HbA1c level below 7.0% (53 mmol/mol) (yes/no)	Number of participants	At end of study (week 28 to 38)
Patient reported severe or documented hypoglycaemia (yes/no)	Number of participants	Between baseline (week 0), end of study (week 28-38)
Patient completed the study under treatment with semaglutide (yes/no)	Number of participants	At end of study (week 28 to 38)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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 Mar 4. doi: 10.1111/dom.15045. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9535-4495; U1111-1222-5620 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No