NCT04083820|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)

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN9535-4495U1111-1222-5620

Study Type

observational

Target

521

Locations

1 country

Sites

Timeline

RegisteredSep 2019

StartedSep 2019

CompletionSep 2021

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

521

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach

1 country

53 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

September 6, 2019

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed

6 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed

Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

September 6, 2019

Last Update Submit

March 24, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

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 Outcomes (16)

Change in body weight
Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in body weight
Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in waist circumference
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)
At end of study (week 28 to 38)
HbA1c level below 7.5% (59 mmol/mol) (yes/no)
At end of study (week 28 to 38)
+11 more secondary outcomes

Study Arms (1)

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

Interventions

semaglutideDRUG

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 s.c. once-weekly

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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 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 haemoglobin A1c (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

Contact the study team to confirm eligibility.