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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1255-5644 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire survey | Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Time to first occurrence of a composite of obesity related cancer defined by WHO | Measured in months |
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Inclusion Criteria:
Exclusion criteria:
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Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Master Centre for USA | Plainsboro | New Jersey | 08536 | United States | ||
| Master Centre for Algeria |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Algiers |
| 16035 |
| Algeria |
| Master Centre for Argentina | Prov. de Buenos Aires | B1636DSU | Argentina |
| Master Centre for Australia | North Sydney | New South Wales | 2060 | Australia |
| Cárdio Pulmonar da Bahia | Salvador | Estado de Bahia | 40170130 | Brazil |
| Hospital do Coração do Brasil | Brasília | Federal District | 70390-700 | Brazil |
| Eurolatino Medical Research Center | Uberlândia | Minas Gerais | 38400-500 | Brazil |
| Núcleo de Pesquisa Clínica S/S | Curitiba | Paraná | 80730-150 | Brazil |
| Hospital São Vicente de Paulo | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| AngioCor Blumenau | Blumenau | Santa Catarina | 89020-430 | Brazil |
| Instituto de Pesquisa Clínica de Campinas | Campinas | São Paulo | 13060-080 | Brazil |
| CIP Centro Integrado de Pesquisas do Hospital de Base | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| CPQuali Pesquisa Clínica Ltda | São Paulo | São Paulo | 01228-000 | Brazil |
| CPCLIN - Centro de Pesquisas Clínicas | São Paulo | São Paulo | 01228-200 | Brazil |
| Instituto Dante Pazzanese de Cardiologia | São Paulo | São Paulo | 04012-909 | Brazil |
| Departamento de Gastroenterologia - HCFMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Instituto do Coração - HCFMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Master Centre for Brazil | Säo Paulo | São Paulo | 05001-100 | Brazil |
| Instituto Brasil de Pesquisa Clinica | Rio de Janeiro | 20241-180 | Brazil |
| Master Centre for Canada | Mississauga | Ontario | L4W 4XI | Canada |
| Novo Nordisk Croatia Ltd. | Zagreb | 10 020 | Croatia |
| Master Centre for Denmark | Copenhagen S | 2300 | Denmark |
| Master Centre for Finland | Espoo | FI-02600 | Finland |
| Master Centre for Germany PMS | Mainz | 55124 | Germany |
| Master Centre for Greece | Vouliagment | 16671 | Greece |
| Master centre for India | Bangalore | 560001 | India |
| Master Centre for Ireland | Dublin | D09 X8W3 | Ireland |
| Master Centre for Italy | Rome | 00144 | Italy |
| Master Centre for Japan | Tokyo | 1000005 | Japan |
| MAster Centre for Latvia | Marupes | 2167 | Latvia |
| Master Centre for Malaysia | Selangor Darul Ehsan | Malaysia |
| Master Centre Netherlands | Alphen aan den Rijn | 2408 AV | Netherlands |
| Master Centre for Norway | Rud | 1309 | Norway |
| Master Centre for South Africa | Sandton | Gauteng | 2146 | South Africa |
| Master Centre for Sweden | Malmö | 202 15 | Sweden |
| Master Centre for Tawain | Taipei | 106 | Taiwan |
| Master Centre for Thailand | Bangkok | 10500 | Thailand |
| Master Centre for United Kingdom | Gatwick | West Sussex | RH6 0PA | United Kingdom |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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