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

NCT ID: NCT04261933

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

789 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-13

Study Completion Date

2021-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

semaglutide

Intervention Type DRUG

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.

Interventions

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semaglutide

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.

Intervention Type DRUG

Eligibility Criteria

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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 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor & Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Amberg, , Germany

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Aschaffenburg, , Germany

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Augsburg, , Germany

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Bad Mergentheim, , Germany

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Bad Oeynhausen, , Germany

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Bautzen, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bernau bei Berlin, , Germany

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Bonn, , Germany

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Bramsche, , Germany

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Cologne, , Germany

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Cologne, , Germany

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Darmstadt, , Germany

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Dessau, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Duisburg, , Germany

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Eisenach, , Germany

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Elsterwerda, , Germany

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Erdmannhausen, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Essen, , Germany

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Forst, , Germany

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Freisen, , Germany

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Friedrichsthal, , Germany

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Fulda, , Germany

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Gebhardshain, , Germany

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Gelnhausen, , Germany

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Grasleben, , Germany

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Großröhrsdorf, , Germany

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Grünstadt, , Germany

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Hainburg, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hammelburg, , Germany

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Hanover, , Germany

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Heidenheim, , Germany

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Herrenberg, , Germany

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Hof, , Germany

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Hohenmölsen, , Germany

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Jena, , Germany

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Kempten (Allgäu), , Germany

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Leipzig, , Germany

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Lichtenfels, , Germany

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Lingen, , Germany

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Ludwigsburg, , Germany

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Magdeburg, , Germany

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Marburg, , Germany

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Marburg, , Germany

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Mayen, , Germany

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Meckesheim, , Germany

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Mössingen, , Germany

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Mühldorf, , Germany

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Mülheim, , Germany

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München, , Germany

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München, , Germany

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Münster, , Germany

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Neustrelitz, , Germany

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Nuremberg, , Germany

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Oranienburg, , Germany

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Osnabrück, , Germany

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Otterbach, , Germany

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Pohlheim, , Germany

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Rellingen, , Germany

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Rostock, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

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Schorndorf, , Germany

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Schönhausen (Elbe), , Germany

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Schwerin, , Germany

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Seelow, , Germany

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Soltau, , Germany

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Sonsbeck, , Germany

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Speyer, , Germany

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Spremberg, , Germany

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Stadtbergen, , Germany

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Straubing, , Germany

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Stuttgart, , Germany

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Stuttgart, , Germany

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Trier, , Germany

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Ulm, , Germany

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Viersen, , Germany

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Villingen-Schwenningen, , Germany

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Villingen-Schwenningen, , Germany

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Wedemark, , Germany

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Wetzlar, , Germany

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Wiesloch, , Germany

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Witzenhausen, , Germany

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Wolmirstedt, , Germany

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Wurzen, , Germany

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Zwenkau, , Germany

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Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 36809678 (View on PubMed)

Other Identifiers

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U1111-1241-6291

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4617

Identifier Type: -

Identifier Source: org_study_id

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