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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)

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: NCT04972721
Recruitment Status : Enrolling by invitation
First Posted : July 22, 2021
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date July 13, 2021
First Posted Date July 22, 2021
Last Update Posted Date March 31, 2022
Actual Study Start Date November 16, 2021
Estimated Primary Completion Date April 1, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial
Official Title SELECT-LIFE (SELECT Follow-up Study to Evaluate Long-term Impact oF Anti-obEsity Medication)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Overweight
  • Obesity
Intervention 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.
Study Groups/Cohorts Questionnaire survey
Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends.
Intervention: Other: No treatment given
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 13, 2021)
12450
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2032
Estimated Primary Completion Date April 1, 2032   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Canada,   France,   Germany,   Greece,   Italy,   Malaysia,   Thailand,   United Kingdom,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number NCT04972721
Other Study ID Numbers EX9536-4750
U1111-1255-5644 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Clinical Transparency (dept. 2834) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date March 2022