A Study of Cardiovascular Events iN Diabetes Plus

Sponsor
University of Oxford
Study ID
NCT05441267
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Oral Tablet — DRUG
    Oral semaglutide 14mg daily (option to reduce to 7mg daily)
  • Placebo oral tablet — DRUG
    Placebo oral semaglutide

Study Details

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.

Key Dates

Start date
Mar 13, 2023
Status verified
May 2024
Primary completion
Aug 17, 2028
Completion
Aug 17, 2048

Study Design

Enrollment
20,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Oral semaglutide
    14mg daily (option to reduce to 7mg daily)
  • Placebo Comparator: Placebo

Primary Outcome Measure

Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE+) [ Time Frame: Scheduled treatment period (anticipated median follow-up period of 5-years) ]

Central Contacts

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