SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial
- Conditions
- OverweightObesity
- Interventions
- Other: No treatment given
- Registration Number
- NCT04972721
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3400
- Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Questionnaire survey No treatment given Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends.
- Primary Outcome Measures
Name Time Method Time to diagnosis of type 2 diabetes 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 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 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 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 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 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 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 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) 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.
Time to all-cause death 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 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 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 Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10) From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) Days
Time to first occurrence of bariatric surgery 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) 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
Time to first occurrence of a composite of obesity related cancer defined by WHO 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Master Centre for Italy
🇮🇹Rome, Italy
Master Centre for Japan
🇯🇵Tokyo, Japan
MAster Centre for Latvia
🇱🇻Marupes, Latvia
Master Centre for Malaysia
🇲🇾Selangor Darul Ehsan, Malaysia
Master Centre Netherlands
🇳🇱Alphen A/d Rijn, Netherlands
Master Centre for Norway
🇳🇴Rud, Norway
Master Centre for South Africa
🇿🇦Sandton, Gauteng, South Africa
Master Centre for Sweden
🇸🇪Malmö, Sweden
Master Centre for Tawain
🇨🇳Taipei, Taiwan
Master Centre for Thailand
🇹ðŸ‡Bangkok, Thailand
Master Centre for United Kingdom
🇬🇧Gatwick, West Sussex, United Kingdom
Master Centre for USA
🇺🇸Plainsboro, New Jersey, United States
Master Centre for Algeria
🇩🇿Algiers, Algeria
Master Centre for Argentina
🇦🇷Prov. De Buenos Aires, Argentina
Master Centre for Australia
🇦🇺Baulkham Hills, New South Wales, Australia
Cárdio Pulmonar da Bahia
🇧🇷Salvador, Bahia, Brazil
Hospital do Coração do Brasil
🇧🇷Brasilia, Distrito Federal, Brazil
Eurolatino Medical Research Center
🇧🇷Uberlândia, Minas Gerais, Brazil
Núcleo de Pesquisa ClÃnica S/S
🇧🇷Curitiba, Parana, Brazil
Hospital São Vicente de Paulo
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
AngioCor Blumenau
🇧🇷Blumenau, Santa Catarina, Brazil
Instituto de Pesquisa ClÃnica de Campinas
🇧🇷Campinas, Sao Paulo, Brazil
CIP Centro Integrado de Pesquisas do Hospital de Base
🇧🇷São José do Rio Preto, Sao Paulo, Brazil
CPQuali Pesquisa ClÃnica Ltda
🇧🇷São Paulo, Sao Paulo, Brazil
CPCLIN - Centro de Pesquisas ClÃnicas
🇧🇷São Paulo, Sao Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷São Paulo, Sao Paulo, Brazil
Departamento de Gastroenterologia - HCFMUSP
🇧🇷São Paulo, Sao Paulo, Brazil
Instituto do Coração - HCFMUSP
🇧🇷São Paulo, Sao Paulo, Brazil
Master Centre for Brazil
🇧🇷Säo Paulo, Sao Paulo, Brazil
Instituto Brasil de Pesquisa Clinica
🇧🇷Rio de Janeiro, Brazil
Master Centre for Canada
🇨🇦Mississauga, Ontario, Canada
Novo Nordisk Croatia Ltd.
ðŸ‡ðŸ‡·Zagreb, Croatia
Master Centre for Denmark
🇩🇰Copenhagen S, Denmark
Master Centre for Finland
🇫🇮Espoo, Finland
Master Centre for Germany PMS
🇩🇪Mainz, Germany
Master Centre for Greece
🇬🇷Vouliagment, Greece
Master centre for India
🇮🇳Bangalore, India
Master Centre for Ireland
🇮🇪Dublin 9, Ireland