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

NCT ID: NCT03876015

Last Updated: 2021-01-19

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

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-08-12

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.

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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

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 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
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 and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Atherstone, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Berkshire, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bradford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Brighton, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Camberley, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Cambridgeshire, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Chiswick, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Co Durham, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Coventry, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Darlington, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Dudley, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Durham, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Greenisland, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Halifax, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Hull, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Kettering, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Leicester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Leicestershire, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Lincs, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Machester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Manchester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Merseyside, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Nuneaton, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Rayleigh, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Rhyl, , United Kingdom

Site Status

Novo Nordisk Investigational Site

South Shields, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Southampton, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Walton on Thames, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Watford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Wellingborough, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35383100 (View on PubMed)

Holmes P, Bell HE, Bozkurt K, Catarig AM, Clark A, Machell A, Sathyapalan T. Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study. Diabetes Ther. 2021 Nov;12(11):2891-2905. doi: 10.1007/s13300-021-01141-8. Epub 2021 Sep 25.

Reference Type DERIVED
PMID: 34562237 (View on PubMed)

Other Identifiers

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U1111-1199-9050

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4366

Identifier Type: -

Identifier Source: org_study_id

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