| Trial ID: | L2823 |
| Source ID: | NCT05441267
|
| Associated Drug: |
Semaglutide Oral Tablet
|
| Title: |
A Study of Cardiovascular Events iN Diabetes Plus
|
| Acronym: |
ASCEND PLUS
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Semaglutide Oral Tablet|DRUG: Placebo oral tablet
|
| Outcome Measures: |
Primary: Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE+), MACE+ is an expanded composite, defined as: * Death from cardiovascular disease * Non-fatal myocardial infarction * Non-fatal stroke * Transient ischaemic attack * Coronary revascularisation, Scheduled treatment period (anticipated median follow-up period of 5-years) | Secondary: Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE), MACE is a composite, defined as: * Death from cardiovascular disease * Non-fatal myocardial infarction * Non-fatal stroke, Scheduled treatment period (anticipated median follow-up period of 5-years)
|
| Sponsor/Collaborators: |
Sponsor: University of Oxford | Collaborators: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
20000
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2023-03-13
|
| Completion Date: |
2048-08-17
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-08
|
| Locations: |
Clinical Trial Service Unit and Epidemiological Studies Unit, Oxford, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT05441267
|
