- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929679
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice (SURE NETHERLANDS) (SURE NL)
January 19, 2023 updated by: Novo Nordisk A/S
A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Onceweekly 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
Study Type
Observational
Enrollment (Actual)
218
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alkmaar, Netherlands, 1815 JD
- Novo Nordisk Investigational Site
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Almelo, Netherlands, 7609PT
- Novo Nordisk Investigational Site
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Almere, Netherlands, 1328 MB
- Novo Nordisk Investigational Site
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Amersfoort, Netherlands, 3813 TZ
- Novo Nordisk Investigational Site
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Arnhem, Netherlands, 6815 AD
- Novo Nordisk Investigational Site
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Bladel, Netherlands, 5531HG
- Novo Nordisk Investigational Site
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Den Bosch, Netherlands, 5223 KE
- Novo Nordisk Investigational Site
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Den Haag, Netherlands, 2585EJ
- Novo Nordisk Investigational Site
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Dordrecht, Netherlands, 3318 AT
- Novo Nordisk Investigational Site
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Eindhoven, Netherlands, 5623 EJ
- Novo Nordisk Investigational Site
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Eindhoven, Netherlands, 5631 BM
- Novo Nordisk Investigational Site
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Emmen, Netherlands, 7811 GW
- Novo Nordisk Investigational Site
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Enschede, Netherlands, 7544 BA
- Novo Nordisk Investigational Site
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Gemert, Netherlands, 5421DB
- Novo Nordisk Investigational Site
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Groningen, Netherlands, 9713 GZ
- Novo Nordisk Investigational Site
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Heerlen, Netherlands, 6417VV
- Novo Nordisk Investigational Site
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Hoogeveen, Netherlands, 7909 AA
- Novo Nordisk Investigational Site
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Leiden, Netherlands, 2332AA
- Novo Nordisk Investigational Site
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Montfort, Netherlands, 6065 AM
- Novo Nordisk Investigational Site
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Nijverdal, Netherlands, 7442 LS
- Novo Nordisk Investigational Site
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Rotterdam, Netherlands, 3083 AN
- Novo Nordisk Investigational Site
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Sint Anthonis, Netherlands, 5845BL
- Novo Nordisk Investigational Site
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Utrecht, Netherlands, 3584 CX
- Novo Nordisk Investigational Site
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Warmenhuizen, Netherlands, 1749 AM
- Novo Nordisk Investigational Site
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Zaandam, Netherlands, 1506WR
- Novo Nordisk Investigational Site
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Zevenbergen, Netherlands, 4761 NG
- Novo Nordisk Investigational Site
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Zwijndrecht, Netherlands, 3331 LZ
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Measured in % point
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Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
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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)
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Measured in mmol/mol
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Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Measured in kg
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Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
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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)
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Measured in %
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Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
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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)
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Measured in cm
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Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
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HbA1c level below 8.0% (64 mmol/mol) (yes/no)
Time Frame: At end of study (week 28 to 38)
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Number of participants
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At end of study (week 28 to 38)
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HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)
Time Frame: At end of study (week 28 to 38)
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Number of participants
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At end of study (week 28 to 38)
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HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)
Time Frame: At end of study (week 28 to 38)
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Number of participants
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At end of study (week 28 to 38)
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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)
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Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more
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Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
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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)
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Number of participants who achieved/not achieved weight reduction of 3.0% or more
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Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
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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)
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Number of participants who achieved/not achieved weight reduction of 5.0% or more
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Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
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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)
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Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more
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Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
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Patient reported severe or documented hypoglycaemia (yes/no)
Time Frame: Between baseline (week 0), end of study (week 28-38)
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Number of patients
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Between baseline (week 0), end of study (week 28-38)
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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)
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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
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Baseline (week 0), end of study (week 28 to 38)
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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)
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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
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Baseline (week 0), end of study (week 28 to 38)
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Change in score for Short Form (SF)-36 v2: Physical summary component
Time Frame: Baseline (week 0), end of study (week 28 to 38)
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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).
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Baseline (week 0), end of study (week 28 to 38)
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Change in score for SF-36 v2: Mental summary component
Time Frame: Baseline (week 0), end of study (week 28 to 38)
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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).
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Baseline (week 0), end of study (week 28 to 38)
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Patient completed the study under treatment with semaglutide (yes/no)
Time Frame: At end of study (week 28 to 38)
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Number of patients
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At end of study (week 28 to 38)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2019
Primary Completion (Actual)
November 24, 2020
Study Completion (Actual)
November 24, 2020
Study Registration Dates
First Submitted
April 24, 2019
First Submitted That Met QC Criteria
April 24, 2019
First Posted (Actual)
April 29, 2019
Study Record Updates
Last Update Posted (Actual)
January 20, 2023
Last Update Submitted That Met QC Criteria
January 19, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9535-4496
- U1111-1222-5565 (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 drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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