SURE FRANCE

Completed

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

521

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤12%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04083820

Org study IDNN9535-4495

Secondary IDU1111-1222-5620World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-09-10actual

Study start2019-09-16actual

Primary completion2021-09-27actual

Study completion2021-09-27actual

Last update posted2023-03-28actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Participants with type 2 diabetes

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Change in body weight

Time frame:Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

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

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Weight reduction of 3.0% or more (yes/no)

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

threshold achievement, improvement

Secondary/protocol endpoint

Weight reduction of 5.0% or more (yes/no)

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

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Change in Glycated Haemoglobin A1c (HbA1c)

Time frame:Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change in Glycated Haemoglobin A1c (HbA1c)

Time frame:Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c level below 8.0% (64 mmol/mol) (yes/no)

Time frame:At end of study (week 28 to 38)

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c level below 7.5% (59 mmol/mol) (yes/no)

Time frame:At end of study (week 28 to 38)

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c level below 7.0% (53 mmol/mol) (yes/no)

Time frame:At end of study (week 28 to 38)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Reduction in HbA1c of 1.0% point or more (yes/no)

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

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction

Time frame:Baseline (week 0), end of study (week 28 to 38)

change from baseline, improvement

Secondary/protocol endpoint

Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction

Time frame:Baseline (week 0), end of study (week 28 to 38)

change from baseline, improvement

Secondary/protocol endpoint

Change in score for Short Form (SF)-36 v2: Physical summary component

Time frame:Baseline (week 0), end of study (week 28 to 38)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in score for SF-36 v2: Mental summary component

Time frame:Baseline (week 0), end of study (week 28 to 38)

SF-36 mental

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Patient reported severe or documented hypoglycaemia (yes/no)

Time frame:Between baseline (week 0), end of study (week 28-38)

Documented hypoglycemia

categorical status, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Patient completed the study under treatment with semaglutide (yes/no)

Time frame:At end of study (week 28 to 38)

categorical status, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)

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

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Once-weekly semaglutide use in patients with type 2 diabetes: Results from the SURE France multicentre, prospective, observational study.
Diabetes, obesity & metabolism2023 Jul (month)PMID36869853doi:10.1111/dom.15045via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.