NCT05441267

A Study of Cardiovascular Events iN Diabetes Plus

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20,000 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

ASCEND PLUS is testing whether, for people with type 2 diabetes who have not previously had a heart attack or stroke, regularly taking a tablet called semaglutide can safely help to reduce heart attacks, strokes, mini-strokes, the need for any procedures to unblock or bypass an artery to their heart, and the chance of dying because of vascular problems.

Detailed description

ASCEND PLUS aims to assess the effects of the GLP1 receptor agonist, oral semaglutide, on major adverse cardiovascular events in people with type 2 diabetes who have not previously suffered a heart attack or stroke. The study will be conducted using novel, streamlined methodology. Participants will be identified from centrally held routinely collected NHS healthcare datasets and invited to join the trial. There will be no physical sites, and all interactions with participants will be conducted directly using innovative patient-centred web-based technology, supplemented by telephone, video call contact and mailed letters. Study treatment will be mailed to participants. Information regarding serious adverse events and study outcomes relevant to patients with type 2 diabetes mellitus will be collected by regular linkage to UK National Health Service health records both during the scheduled treatment period and for the subsequent 20 years' long term follow-up after the scheduled treatment period. The trial design includes an active run-in phase, prior to randomisation, during which participants will be asked to take 4-weeks of active 3mg oral semaglutide followed by 4 to 8-weeks of active 7mg oral semaglutide daily. Participants who are randomised will be allocated to receive either 14mg oral semaglutide or matching placebo daily during the scheduled treatment period. There will be the opportunity to reduce the dose to 7mg or matching placebo if required. The scheduled treatment period, during which participants are requested to take the study treatment and complete follow-up assessments, is anticipated to continue until the required number of participants has experienced a primary outcome following randomisation. This is expected to occur at a median of approximately 5 years after randomisation.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide Oral Tablet	Oral semaglutide 14mg daily (option to reduce to 7mg daily)
DRUG	Placebo oral tablet	Placebo oral semaglutide

Timeline

• Start date: 2023-03-13
• Primary completion: 2028-08-17
• Completion: 2048-08-17
• First posted: 2022-07-01
• Last updated: 2024-05-08

Locations

1 site across 1 country: United Kingdom