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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) (SURE UK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03876015
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Semaglutide

Study Design
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Study Type : Observational
Actual Enrollment : 215 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : August 12, 2020
Actual Study Completion Date : August 12, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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) ]
    Measured in kg

  2. 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) ]
    Measured in %

  3. 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) ]
    Measured in cm

  4. HbA1c level at end of study: <8.0% (64 mmol/mol) (yes/no) [ Time Frame: At end of study (week 28 to 38) ]
    Number of participants who achieved/not achieved HbA1c level at end of study: <8.0%

  5. HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no) [ Time Frame: At end of study (week 28 to 38) ]
    Number of participants who achieved/not achieved HbA1c level at end of study: <7.5%

  6. HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no) [ Time Frame: At end of study (week 28 to 38) ]
    Number of participants who achieved/not achieved HbA1c level at end of study: <7.0%

  7. 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) ]
    Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more

  8. 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) ]
    Number of participants who achieved/not achieved weight reduction of 3.0% or more

  9. 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) ]
    Number of participants who achieved/not achieved weight reduction of 5.0% or more

  10. 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) ]
    Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more

  11. Patient reported severe or documented hypoglycaemia (yes/no) [ Time Frame: Between baseline (week 0), end of study (week 28-38) ]
    Number of patients who reported/not reported severe or documented hypoglycaemia

  12. 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) ]
    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.

  13. 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) ]
    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

  14. Change in score for Short Form (SF)-36 v2: Physical summary component [ Time Frame: Baseline (week 0), end of study (week 28 to 38) ]
    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).

  15. Change in score for SF-36 v2: Mental summary component [ Time Frame: Baseline (week 0), end of study (week 28 to 38) ]
    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).

  16. Patient completed the study under treatment with semaglutide (yes/no) [ Time Frame: At end of study (week 28 to 38) ]
    Number of patients who completed/not completed the study under treatment with semaglutide


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with type 2 diabetes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876015


Locations
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United Kingdom
Novo Nordisk Investigational Site
Atherstone, United Kingdom, CV9 1EU
Novo Nordisk Investigational Site
Berkshire, United Kingdom, SL2 1HD
Novo Nordisk Investigational Site
Bradford, United Kingdom, BD14 6ES
Novo Nordisk Investigational Site
Brighton, United Kingdom, BN2 3EW
Novo Nordisk Investigational Site
Camberley, United Kingdom, GU16 7UJ
Novo Nordisk Investigational Site
Cambridgeshire, United Kingdom, PE8 6PL
Novo Nordisk Investigational Site
Chiswick, United Kingdom, W4 3JL
Novo Nordisk Investigational Site
Co Durham, United Kingdom, DH9 8AD
Novo Nordisk Investigational Site
Coventry, United Kingdom, CV6 5BG
Novo Nordisk Investigational Site
Darlington, United Kingdom, DL2 1BY
Novo Nordisk Investigational Site
Dudley, United Kingdom, DY1 2HQ
Novo Nordisk Investigational Site
Durham, United Kingdom, DL3 8SQ
Novo Nordisk Investigational Site
Greenisland, United Kingdom, BT38 8TP
Novo Nordisk Investigational Site
Halifax, United Kingdom, HX2 0QL
Novo Nordisk Investigational Site
Hull, United Kingdom, HU3 2RW
Novo Nordisk Investigational Site
Kettering, United Kingdom, NN16 8UZ
Novo Nordisk Investigational Site
Leicestershire, United Kingdom, LE12 6JG
Novo Nordisk Investigational Site
Leicester, United Kingdom, LE3 1HN
Novo Nordisk Investigational Site
Lincs, United Kingdom, LN11 7QU
Novo Nordisk Investigational Site
London, United Kingdom, SW19 2BY
Novo Nordisk Investigational Site
Machester, United Kingdom, M22 4DH
Novo Nordisk Investigational Site
Manchester, United Kingdom, M8 5RB
Novo Nordisk Investigational Site
Merseyside, United Kingdom, CH43 9JW
Novo Nordisk Investigational Site
Nuneaton, United Kingdom, CV10 7DJ
Novo Nordisk Investigational Site
Rayleigh, United Kingdom, SS6 7DY
Novo Nordisk Investigational Site
Rhyl, United Kingdom, LL18 1DA
Novo Nordisk Investigational Site
South Shields, United Kingdom, NE34 6RE
Novo Nordisk Investigational Site
Southampton, United Kingdom, SO30 3JB
Novo Nordisk Investigational Site
Walton on Thames, United Kingdom, Kt12 4HT
Novo Nordisk Investigational Site
Watford, United Kingdom, WD25 7NL
Novo Nordisk Investigational Site
Wellingborough, United Kingdom, NN8 4RW
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03876015    
Other Study ID Numbers: NN9535-4366
U1111-1199-9050 ( Other Identifier: World Health Organisation (WHO) )
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases