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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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)

Clinicaltrials.gov identifier NCT03929679

Recruitment Status Active, not recruiting

First Posted April 29, 2019

Last update posted October 12, 2020

Study Description

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:Diabetes Mellitus, Type 2
  • Intervention/Treatment: Drug: semaglutide
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual 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 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: November 2020
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • 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
Eligibility Criteria
  • 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
Contacts
Locations
Show 27 Study Locations
Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

More Information
  • Responsible Party: Novo Nordisk A/S
  • ClinicalTrials.gov Identifier: NCT03929679 History of Changes
  • Other Study ID Numbers: NN9535-4496, U1111-1222-5565
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: October 12, 2020
  • Last Verified: October 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
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 2