A Study of Cardiovascular Events iN Diabetes Plus

What Was Tested

This registered phase 4 trial tested Semaglutide.

It had two arms (groups): Oral semaglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 21296 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults aged at least 55 years at the time of the Screening assessment. Type 2 Diabetes Mellitus (based on self-reported medical history).

The full record lists 2 inclusion and 19 exclusion criteria; among the exclusions: myocardial infarction; current or planned treatment with a glp-1 ra; previous hypersensitivity to or intolerance of glp-1 ra therapy.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-03-13 with completion listed for 2028-08-17.

It ran at 1 site in United Kingdom.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): 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)).

It also tracked 1 secondary outcome, for example Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 21296 people.

With 21296 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.