A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Denmark and Sweden, as Part of Local Clinical Practice (SURE DENMARK/SWEDEN)

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Semaglutide
How many people: 333 participants
Where: 30 sitesin 2 countries
Study dates: 24 Aug 2018to 10 Jan 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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

Trial locations and contacts

30 sites in 2 countries.

Country

City, postcode or hospital

30 sites in 2 countries

Sweden29 sites

Novo Nordisk Investigational Site
Åkersberga, 184 50
Novo Nordisk Investigational Site
Ängelholm, 262 81
Novo Nordisk Investigational Site
Avesta, 774 41
Novo Nordisk Investigational Site
Bjärred, 23731
Novo Nordisk Investigational Site
Bollnäs, 821 31
Novo Nordisk Investigational Site
Charlottenberg, 67332
Novo Nordisk Investigational Site
Eslöv, 24131
Novo Nordisk Investigational Site
Falköping, 512 85
Novo Nordisk Investigational Site
Flen, 642 32
Novo Nordisk Investigational Site
Gothenburg, 417 22
Novo Nordisk Investigational Site
Härnösand, 871 82
Novo Nordisk Investigational Site
Helsingborg, 252 26
Novo Nordisk Investigational Site
Huskvarna, 551 85
Novo Nordisk Investigational Site
Karlskoga, 691 81
Novo Nordisk Investigational Site
Kungsbacka, 434 40
Novo Nordisk Investigational Site
Laholm, 312 80
Novo Nordisk Investigational Site
Luleå, 972 33
Novo Nordisk Investigational Site
Lund, 22221
Novo Nordisk Investigational Site
Mölndal, 431 31
Novo Nordisk Investigational Site
Nässjö, 571 81
Novo Nordisk Investigational Site
Nybro, 38230
Novo Nordisk Investigational Site
Örebro, 70235
Novo Nordisk Investigational Site
Sala, 733 38
Novo Nordisk Investigational Site
Staffanstorp, 24531
Novo Nordisk Investigational Site
Stockholm, 113 65
Novo Nordisk Investigational Site
Sundsvall, 85463
Novo Nordisk Investigational Site
Uddevalla, 451 72
Novo Nordisk Investigational Site
Upplands Vasby, 194 34
Novo Nordisk Investigational Site
Västerås, 722 11

Other trials in Sweden

Denmark1 site

Novo Nordisk Investigational Site
Søborg

Other trials in Denmark

About this study

Official title: SURE DENMARK/SWEDEN: A Multi-centre, Prospective, Non-interventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

Conditions: Diabetes Mellitus, Type 2
Being tested: Semaglutide
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03648281
Study group	Role	What they receive
Semaglutide		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. Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glycated Haemoglobin A1c (HbA1c)
Measured in % points
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in HbA1c
Measured in mmol/mol
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Secondary outcomes (16)

Change in body weight
Measured in kg
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in body weight
Measured in %
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in waist circumference
Measured in cm
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
HbA1c level at end of study: <8.0% (64 mmol/mol) (yes/no)
Number of participants who achieved/not achieved HbA1c level at end of study: <8.0%
Measured: At end of study (week 28 to 38)
HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no)
Number of participants who achieved/not achieved HbA1c level at end of study: <7.5%
Measured: At end of study (week 28 to 38)
HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no)
Number of participants who achieved/not achieved HbA1c level at end of study: <7.0%
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Patient reported severe or documented hypoglycaemia (yes/no)
Number of patients who reported/not reported severe or documented hypoglycaemia
Measured: Between baseline (week 0) and end of study (week 28-38)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline (week 0), end of study (week 28 to 38)
Patient completed the study under treatment with semaglutide (yes/no)
Number of patients who completed/not completed the study under treatment with semaglutide
Measured: At end of study (week 28 to 38)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 201810 Jan 2020

First posted27 Aug 2018
Study start24 Aug 2018
Primary completion10 Jan 2020
Study completion10 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03648281
Sponsor's protocol ID: NN9535-4367
Other IDs: U1111-1204-5181
Status last verified: Nov 2021
First submitted: 24 Aug 2018
Last updated: 15 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

Rajamand Ekberg N, Bodholdt U, Catarig AM, Catrina SB, Grau K, Holmberg CN, Klanger B, Knudsen ST. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational study. Prim Care Diabetes. 2021 Oct;15(5):871-878. doi: 10.1016/j.pcd.2021.06.008. Epub 2021 Jun 25.
PubMed 34183269
Yale JF, Bodholdt U, Catarig AM, Catrina S, Clark A, Ekberg NR, Erhan U, Holmes P, Knudsen ST, Liutkus J, Sathyapalan T, Schultes B, Rudofsky G. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: pooled analysis of data from four SURE studies by baseline characteristic subgroups. BMJ Open Diabetes Res Care. 2022 Apr;10(2):e002619. doi: 10.1136/bmjdrc-2021-002619.
PubMed 35383100

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SURE DENMARK/SWEDEN: A Multi-centre, Prospective, Non-interventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes
ClinicalTrials.gov ID: NCT03648281
Acronym / sponsor ID: NN9535-4367
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 333 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 24 Aug 2018 (actual)
Primary completion: 10 Jan 2020 (actual)
Study completion: 10 Jan 2020 (actual)
First posted: 27 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Semaglutide	–	Drug: SemaglutideParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with type 2 diabetes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SemaglutidePatients 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.	Drug	Semaglutide

Primary outcome

Change in Glycated Haemoglobin A1c (HbA1c)
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Measured in % points
Change in HbA1c
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Measured in mmol/mol

16 secondary outcomes

Change in body weight
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in body weight
Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
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)
HbA1c level at end of study: <8.0% (64 mmol/mol) (yes/no)
Time frame: At end of study (week 28 to 38)
HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no)
Time frame: At end of study (week 28 to 38)
HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no)
Time frame: At end of study (week 28 to 38)
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)
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)
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)
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)
Patient reported severe or documented hypoglycaemia (yes/no)
Time frame: Between baseline (week 0) and end of study (week 28-38)
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 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 in score for Short Form (SF)-36 v2: Physical summary component
Time frame: Baseline (week 0), end of study (week 28 to 38)
Change in score for SF-36 v2: Mental summary component
Time frame: Baseline (week 0), end of study (week 28 to 38)
Patient completed the study under treatment with semaglutide (yes/no)
Time frame: At end of study (week 28 to 38)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
Results publication: PubMed 34183269Rajamand Ekberg N, Bodholdt U, Catarig AM, Catrina SB, Grau K, Holmberg CN, Klanger B, Knudsen ST. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational study. Prim Care Diabetes. 2021 Oct;15(5):871-878. doi: 10.1016/j.pcd.2021.06.008. Epub 2021 Jun 25.
Derived from this study: PubMed 35383100Yale JF, Bodholdt U, Catarig AM, Catrina S, Clark A, Ekberg NR, Erhan U, Holmes P, Knudsen ST, Liutkus J, Sathyapalan T, Schultes B, Rudofsky G. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: pooled analysis of data from four SURE studies by baseline characteristic subgroups. BMJ Open Diabetes Res Care. 2022 Apr;10(2):e002619. doi: 10.1136/bmjdrc-2021-002619.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Reporting Anchor and Disclosure (1452) study director

Novo Nordisk A/S

30 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin A1c (HbA1c) (time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03648281, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.