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Trial record 2 of 2 for:    EX9536-4388

SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial (SELECT-LIFE)

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ClinicalTrials.gov Identifier: NCT04972721
Recruitment Status : Not yet recruiting
First Posted : July 22, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial.

SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends.

SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking.

When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study.

Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor.

The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.


Condition or disease Intervention/treatment
Overweight Obesity Other: No treatment given

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Study Type : Observational
Estimated Enrollment : 12450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SELECT-LIFE (SELECT Follow-up Study to Evaluate Long-term Impact oF Anti-obEsity Medication)
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : April 1, 2032
Estimated Study Completion Date : April 1, 2032

Group/Cohort Intervention/treatment
Questionnaire survey
Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends.
Other: No treatment given
The study is non-interventional with no study-specific treatment during the study and the patients will be treated as per Treating Physician's and patient's own discretion.




Primary Outcome Measures :
  1. Time to all-cause death [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  2. Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  3. Time to first occurrence of non-fatal myocardial infarction [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  4. Time to first occurrence of non-fatal stroke [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  5. Time to diagnosis of type 2 diabetes [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  6. Time to first occurrence of any type of cancer [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  7. Time to first occurrence of a composite of obesity related cancer defined by WHO [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  8. Time to first occurrence of knee replacement [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  9. Time to first occurrence of bariatric surgery [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  10. Time to first occurrence of anti-obesity medical treatment [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  11. Time to first occurrence of use of continuous positive airways pressure (CPAP) device [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  12. Total number of myocardial infarctions [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  13. Total number of strokes [ Time Frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) ]
    Measured in months

  14. Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10) [ Time Frame: From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) ]
    Measured in Kg

  15. Change in Patient reported quality of life questionnaire (EQ-5D-5L) from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10) [ Time Frame: From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) ]
    EQ-5D-5L score The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale [VAS]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.

  16. Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10) [ Time Frame: From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) ]
    Days



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends.
Criteria

Inclusion Criteria:

  • Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.
  • Signed SELECT-LIFE consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

Exclusion criteria:

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

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): NCT04972721


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04972721    
Other Study ID Numbers: EX9536-4750
U1111-1255-5644 ( Other Identifier: World Health Organization (WHO) )
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 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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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight