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

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ClinicalTrials.gov Identifier: NCT03929679
Recruitment Status : Enrolling by invitation
First Posted : April 29, 2019
Last Update Posted : August 22, 2019
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 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

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Study Type : Observational
Estimated Enrollment : 217 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Onceweekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : January 21, 2021
Estimated Study Completion Date : January 21, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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) ]
    Measured in % point

  2. 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) ]
    Measured in mmol/mol


Secondary Outcome Measures :
  1. 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) ]
    Measured in kg

  2. 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) ]
    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 below 8.0% (64 mmol/mol) (yes/no) [ Time Frame: At end of study (week 28 to 38) ]
    Number of participants

  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

  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

  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

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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): NCT03929679


Locations
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Netherlands
Novo Nordisk Investigational Site
Almelo, Netherlands, 7609PT
Novo Nordisk Investigational Site
Almere, Netherlands, 1328 MB
Novo Nordisk Investigational Site
Amersfoort, Netherlands, 3813 TZ
Novo Nordisk Investigational Site
Arnhem, Netherlands, 6815 AD
Novo Nordisk Investigational Site
Bladel, Netherlands, 5531HG
Novo Nordisk Investigational Site
Den Bosch, Netherlands, 5223 KE
Novo Nordisk Investigational Site
Den Haag, Netherlands, 2585EJ
Novo Nordisk Investigational Site
Dordrecht, Netherlands, 3318 AT
Novo Nordisk Investigational Site
Eindhoven, Netherlands, 5623 EJ
Novo Nordisk Investigational Site
Eindhoven, Netherlands, 5631 BM
Novo Nordisk Investigational Site
Emmen, Netherlands, 7811 GW
Novo Nordisk Investigational Site
Enschede, Netherlands, 7544 BA
Novo Nordisk Investigational Site
Gemert, Netherlands, 5421DB
Novo Nordisk Investigational Site
Heerlen, Netherlands, 6417VV
Novo Nordisk Investigational Site
Hoogeveen, Netherlands, 7909 AA
Novo Nordisk Investigational Site
Leiden, Netherlands, 2332AA
Novo Nordisk Investigational Site
Montfort, Netherlands, 6065 AM
Novo Nordisk Investigational Site
Nijverdal, Netherlands, 7442 LS
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3083 AN
Novo Nordisk Investigational Site
Sint Anthonis, Netherlands, 5845BL
Novo Nordisk Investigational Site
Warmenhuizen, Netherlands, 1749 AM
Novo Nordisk Investigational Site
Zaandam, Netherlands, 1506WR
Novo Nordisk Investigational Site
Zevenbergen, Netherlands, 4761 NG
Novo Nordisk Investigational Site
Zwijndrecht, Netherlands, 3331 LZ
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: NCT03929679     History of Changes
Other Study ID Numbers: NN9535-4496
U1111-1222-5565 ( Other Identifier: World Health Organization (WHO) )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
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