Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04972721
Other study ID # EX9536-4750
Secondary ID U1111-1255-5644
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date November 30, 2033

Study information

Verified date February 2024
Source Novo Nordisk A/S
Contact Novo Nordisk
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3400
Est. completion date November 30, 2033
Est. primary completion date April 1, 2032
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.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

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
Algeria Master Centre for Algeria Algiers
Argentina Master Centre for Argentina Prov. De Buenos Aires
Australia Master Centre for Australia Baulkham Hills New South Wales
Brazil AngioCor Blumenau Blumenau Santa Catarina
Brazil Hospital do Coração do Brasil Brasilia Distrito Federal
Brazil Instituto de Pesquisa Clínica de Campinas Campinas Sao Paulo
Brazil Núcleo de Pesquisa Clínica S/S Curitiba Parana
Brazil Hospital São Vicente de Paulo Passo Fundo Rio Grande Do Sul
Brazil Instituto Brasil de Pesquisa Clinica Rio de Janeiro
Brazil Cárdio Pulmonar da Bahia Salvador Bahia
Brazil CIP Centro Integrado de Pesquisas do Hospital de Base São José do Rio Preto Sao Paulo
Brazil CPCLIN - Centro de Pesquisas Clínicas São Paulo Sao Paulo
Brazil CPQuali Pesquisa Clínica Ltda São Paulo Sao Paulo
Brazil Departamento de Gastroenterologia - HCFMUSP São Paulo Sao Paulo
Brazil Instituto Dante Pazzanese de Cardiologia São Paulo Sao Paulo
Brazil Instituto do Coração - HCFMUSP São Paulo Sao Paulo
Brazil Master Centre for Brazil Säo Paulo Sao Paulo
Brazil Eurolatino Medical Research Center Uberlândia Minas Gerais
Canada Master Centre for Canada Mississauga Ontario
Croatia Novo Nordisk Croatia Ltd. Zagreb
Denmark Master Centre for Denmark Copenhagen S
Finland Master Centre for Finland Espoo
Germany Master Centre for Germany PMS Mainz
Greece Master Centre for Greece Vouliagment
India Master centre for India Bangalore
Ireland Master Centre for Ireland Dublin 9
Italy Master Centre for Italy Rome
Japan Master Centre for Japan Tokyo
Latvia MAster Centre for Latvia Marupes
Malaysia Master Centre for Malaysia Selangor Darul Ehsan
Netherlands Master Centre Netherlands Alphen A/d Rijn
Norway Master Centre for Norway Rud
South Africa Master Centre for South Africa Sandton Gauteng
Sweden Master Centre for Sweden Malmö
Taiwan Master Centre for Tawain Taipei
Thailand Master Centre for Thailand Bangkok
United Kingdom Master Centre for United Kingdom Crawley
United States Master Centre for USA Plainsboro New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Argentina,  Australia,  Brazil,  Canada,  Croatia,  Denmark,  Finland,  Germany,  Greece,  India,  Ireland,  Italy,  Japan,  Latvia,  Malaysia,  Netherlands,  Norway,  South Africa,  Sweden,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to all-cause death Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of non-fatal myocardial infarction Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of non-fatal stroke Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to diagnosis of type 2 diabetes Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of any type of cancer Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of a composite of obesity related cancer defined by WHO Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of knee replacement Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of bariatric surgery Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of anti-obesity medical treatment Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Time to first occurrence of use of continuous positive airways pressure (CPAP) device Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Total number of myocardial infarctions Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Total number of strokes Measured in months From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10) Measured in Kg From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Primary 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) 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. From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Primary Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10) Days From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2