Diabetes Mellitus, Type 2SURE GERMANYNCT04261933

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

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 95 sites in Germany.

Completed

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

Official record

Search all trials

Trial summary

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: 789 participants
Where: 95 sitesGermany
Study dates: 13 Feb 2020to 25 May 2021
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

Who may be able to join

- 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 18 years or older 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 equal to or below 12 weeks prior to initiation of semaglutide treatment

Who cannot join

- 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

95 sites in 1 country.

City, postcode or hospital

95 sites in 1 country

Germany95 sites

Novo Nordisk Investigational Site
Amberg, 92224
Novo Nordisk Investigational Site
Aschaffenburg, 63739
Novo Nordisk Investigational Site
Augsburg, 86179
Novo Nordisk Investigational Site
Bad Mergentheim, 97980
Novo Nordisk Investigational Site
Bad Oeynhausen, 32549
Novo Nordisk Investigational Site
Bautzen, 02625
Novo Nordisk Investigational Site
Berlin, 10115
Novo Nordisk Investigational Site
Berlin, 12247
Novo Nordisk Investigational Site
Berlin, 13086
Novo Nordisk Investigational Site
Berlin, 13597
Novo Nordisk Investigational Site
Berlin, 14169
Novo Nordisk Investigational Site
Bernau bei Berlin, 16321
Novo Nordisk Investigational Site
Bonn, 53113
Novo Nordisk Investigational Site
Bramsche, 49565
Novo Nordisk Investigational Site
Cologne, 50674
Novo Nordisk Investigational Site
Cologne, 50968
Novo Nordisk Investigational Site
Darmstadt, 64283
Novo Nordisk Investigational Site
Dessau, 06844
Novo Nordisk Investigational Site
Dresden, 01277
Novo Nordisk Investigational Site
Dresden, 01279
Novo Nordisk Investigational Site
Duisburg, 47051
Novo Nordisk Investigational Site
Eisenach, 99817
Novo Nordisk Investigational Site
Elsterwerda, 04910
Novo Nordisk Investigational Site
Erdmannhausen, 71729
Novo Nordisk Investigational Site
Erlangen, 91052
Novo Nordisk Investigational Site
Essen, 45279
Novo Nordisk Investigational Site
Essen, 45335
Novo Nordisk Investigational Site
Forst, 03149
Novo Nordisk Investigational Site
Freisen, 66629
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Fulda, 36037
Novo Nordisk Investigational Site
Gebhardshain, 57580
Novo Nordisk Investigational Site
Gelnhausen, 63571
Novo Nordisk Investigational Site
Grasleben, 38368
Novo Nordisk Investigational Site
Großröhrsdorf, 01900
Novo Nordisk Investigational Site
Grünstadt, 67269
Novo Nordisk Investigational Site
Hainburg, 63512
Novo Nordisk Investigational Site
Halle, 06128
Novo Nordisk Investigational Site
Hamburg, 20097
Novo Nordisk Investigational Site
Hammelburg, 97762
Novo Nordisk Investigational Site
Hanover, 30165
Novo Nordisk Investigational Site
Heidenheim, 89518
Novo Nordisk Investigational Site
Herrenberg, 71083
Novo Nordisk Investigational Site
Hof, 95030
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Jena, 07743
Novo Nordisk Investigational Site
Kempten (Allgäu), 87439
Novo Nordisk Investigational Site
Leipzig, 04159
Novo Nordisk Investigational Site
Lichtenfels, 96215
Novo Nordisk Investigational Site
Lingen, 49808
Novo Nordisk Investigational Site
Ludwigsburg, 71634
Novo Nordisk Investigational Site
Magdeburg, 39104
Novo Nordisk Investigational Site
Marburg, 35037
Novo Nordisk Investigational Site
Marburg, 35039
Novo Nordisk Investigational Site
Mayen, 56727
Novo Nordisk Investigational Site
Meckesheim, 74909
Novo Nordisk Investigational Site
Mössingen, 72116
Novo Nordisk Investigational Site
Mühldorf, 84453
Novo Nordisk Investigational Site
Mülheim, 45468
Novo Nordisk Investigational Site
München, 80331
Novo Nordisk Investigational Site
München, 81477
Novo Nordisk Investigational Site
Münster, 48153
Novo Nordisk Investigational Site
Neustrelitz, 17235
Novo Nordisk Investigational Site
Nuremberg, 90480
Novo Nordisk Investigational Site
Oranienburg, 16515
Novo Nordisk Investigational Site
Osnabrück, 49080
Novo Nordisk Investigational Site
Otterbach, 67731
Novo Nordisk Investigational Site
Pohlheim, 35415
Novo Nordisk Investigational Site
Rellingen, 25462
Novo Nordisk Investigational Site
Rostock, 18109
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, 66386
Novo Nordisk Investigational Site
Schönhausen, 39524
Novo Nordisk Investigational Site
Schorndorf, 73614
Novo Nordisk Investigational Site
Schwerin, 19053
Novo Nordisk Investigational Site
Seelow, 15306
Novo Nordisk Investigational Site
Soltau, 29614
Novo Nordisk Investigational Site
Sonsbeck, 47665
Novo Nordisk Investigational Site
Speyer, 67346
Novo Nordisk Investigational Site
Spremberg, 03130
Novo Nordisk Investigational Site
Stadtbergen, 86391
Novo Nordisk Investigational Site
Straubing, 94315
Novo Nordisk Investigational Site
Stuttgart, 70184
Novo Nordisk Investigational Site
Stuttgart, 70378
Novo Nordisk Investigational Site
Trier, 54292
Novo Nordisk Investigational Site
Ulm, 89073
Novo Nordisk Investigational Site
Viersen, 41747
Novo Nordisk Investigational Site
Villingen-Schwenningen, 78048
Novo Nordisk Investigational Site
Villingen-Schwenningen, 78054
Novo Nordisk Investigational Site
Wedemark, 30900
Novo Nordisk Investigational Site
Wetzlar, 35578
Novo Nordisk Investigational Site
Wiesloch, 69168
Novo Nordisk Investigational Site
Witzenhausen, 37213
Novo Nordisk Investigational Site
Wolmirstedt, 39326
Novo Nordisk Investigational Site
Wurzen, 04808
Novo Nordisk Investigational Site
Zwenkau, 04442

Other trials in Germany

About this study

Official title: 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.

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 NCT04261933
Study group	Role	What they receive
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. 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)
Percent point
Measured: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in HbA1c
mmol/mol
Measured: 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 (kg)
kg
Measured: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in body weight (%)
Percent
Measured: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in waist circumference
cm
Measured: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
HbA1c level below 8.0% (64 mmol/mol) (yes/no)
Number of participants
Measured: At end of study (week 28 to 38)
HbA1c level below 7.5% (59 mmol/mol) (yes/no)
Number of participants
Measured: At end of study (week 28 to 38)
HbA1c level below 7.0% (53 mmol/mol) (yes/no)
Number of participants
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)
Count
Measured: Between baseline (week 0), 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)
Count
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.

13 Feb 202025 May 2021

First posted10 Feb 2020
Study start13 Feb 2020
Primary completion25 May 2021
Study completion25 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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: 789 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04261933
Sponsor's protocol ID: NN9535-4617
Other IDs: U1111-1241-6291
Acronym: SURE GERMANY
Status last verified: Mar 2023
First submitted: 6 Feb 2020
Last updated: 28 Mar 2023
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

Vilsboll T, Lindahl CO, Nielsen NF, Tikkanen CK. Real-world impact of once-weekly subcutaneous semaglutide after 2 years of follow-up: Results from a nationwide observational study in people with type 2 diabetes. Diabetes Obes Metab. 2023 Jun;25(6):1740-1749. doi: 10.1111/dom.15031. Epub 2023 Mar 9.
PubMed 36809678

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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes
ClinicalTrials.gov ID: NCT04261933
Acronym / sponsor ID: SURE GERMANY / NN9535-4617
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 789 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 13 Feb 2020 (actual)
Primary completion: 25 May 2021 (actual)
Study completion: 25 May 2021 (actual)
First posted: 10 Feb 2020 (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 s.c. once-weekly	–	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

Key inclusion criteria (5 listed)

- 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 18 years or older 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 equal to or below 12 weeks prior to initiation of semaglutide treatment

Key exclusion criteria (4 listed)

- 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

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 s.c. once-weekly

Primary outcome

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)
Percent point
Change in HbA1c
Time frame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
mmol/mol

16 secondary outcomes

Change in body weight (kg)
Time frame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
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)
Change in waist circumference
Time frame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
HbA1c level below 8.0% (64 mmol/mol) (yes/no)
Time frame: At end of study (week 28 to 38)
HbA1c level below 7.5% (59 mmol/mol) (yes/no)
Time frame: At end of study (week 28 to 38)
HbA1c level below 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), 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 28 Mar 2023.
Background: PubMed 36809678Vilsboll T, Lindahl CO, Nielsen NF, Tikkanen CK. Real-world impact of once-weekly subcutaneous semaglutide after 2 years of follow-up: Results from a nationwide observational study in people with type 2 diabetes. Diabetes Obes Metab. 2023 Jun;25(6):1740-1749. doi: 10.1111/dom.15031. Epub 2023 Mar 9.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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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
Obesity, Overweight
Not yet recruiting
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Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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 & Disclosure (1452) study director

Novo Nordisk A/S

95 sites in 1 country: 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 95 sites in Germany.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in Germany. 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 (week 0) to 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 NCT04261933, which also lists 1 linked publication.

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 28 Mar 2023.