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

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: NCT04067999
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed to them by their 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. Participants will complete these during their normally scheduled visits with their doctor.

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

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Study Type : Observational
Estimated Enrollment : 217 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SURE SPAIN: 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 : August 5, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

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.The decision to initiate treatment with semaglutide is at the treating physician's discretion, and clearly separated from the decision to include the patient in the study.




Primary Outcome Measures :
  1. Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent) [ 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 Glycated Haemoglobin A1c (HbA1c) (measured in mmol/mol) [ 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 (measured in kg) [ 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 (measured in percent) [ 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: below 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: below 8.0%

  5. HbA1c level at end of study: below 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: below 7.5%

  6. HbA1c level at end of study: below 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: below 7.0%

  7. Reduction in HbA1c from baseline to end of study of 1.0% point or more (Y/N) [ 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) and 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



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 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 less than 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

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): NCT04067999


Locations
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Spain
Novo Nordisk Investigational Site
A Coruña, Spain, 15006
Novo Nordisk Investigational Site
Baracaldo, Spain, 48903
Novo Nordisk Investigational Site
Barcelona, Spain, 08007
Novo Nordisk Investigational Site
Barcelona, Spain, 08036
Novo Nordisk Investigational Site
Bilbao, Spain, 48013
Novo Nordisk Investigational Site
Ferrol, Spain, 15401
Novo Nordisk Investigational Site
Galdakao, Spain, 48960
Novo Nordisk Investigational Site
Las Palmas de Gran Canaria, Spain, 35001
Novo Nordisk Investigational Site
Oviedo, Spain, 33006
Novo Nordisk Investigational Site
Pamplona, Spain, 31008
Novo Nordisk Investigational Site
Pontevedra, Spain, 36071
Novo Nordisk Investigational Site
Ribadeo, Spain, 27700
Novo Nordisk Investigational Site
Salamanca, Spain, 37007
Novo Nordisk Investigational Site
Valladolid, Spain, 47010
Novo Nordisk Investigational Site
Vigo, Spain, 36200
Novo Nordisk Investigational Site
Álava, Spain, 01001
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04067999    
Other Study ID Numbers: NN9535-4368
U1111-1217-3546 ( Other Identifier: World Health Organization (WHO) )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
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