NCT05441267

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
271mo left

Started Mar 2023

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Mar 2023Aug 2048

First Submitted

Initial submission to the registry

June 27, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2028

Expected
20 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2048

Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

5.4 years

First QC Date

June 27, 2022

Last Update Submit

May 7, 2024

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE)

    Scheduled treatment period (anticipated median follow-up period of 5-years)

Study Arms (2)

Oral semaglutide

ACTIVE COMPARATOR

14mg daily (option to reduce to 7mg daily)

Drug: Semaglutide Oral Tablet

Placebo

PLACEBO COMPARATOR
Drug: Placebo oral tablet

Interventions

Semaglutide Oral TabletDRUG

Oral semaglutide 14mg daily (option to reduce to 7mg daily)

Oral semaglutide
Placebo oral tabletDRUG

Placebo oral semaglutide

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged at least 55 years at the time of the Screening assessment
  • Type 2 Diabetes Mellitus (based on self-reported medical history)

You may not qualify if:

  • Myocardial Infarction
  • Stroke
  • Current or planned treatment with a GLP-1 RA
  • Previous hypersensitivity to or intolerance of GLP-1 RA therapy
  • Severe hypoglycaemia within the last six months or during run-in
  • Symptomatic hypoglycaemia within the last month
  • Currently under consideration to commence insulin
  • Severe heart failure (NYHA class 4)
  • Current or planned renal replacement therapy
  • Unwilling to complete regular follow-up assessments
  • Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years
  • Type 1 or other type of diabetes (e.g. MODY)
  • History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • Currently breastfeeding or pregnant, or planning a pregnancy
  • Any serious illness which is likely to limit survival or active participation for at least 5 years
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Service Unit and Epidemiological Studies Unit

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Preiss

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Marion Mafham

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryonfa Lee

CONTACT

01865 743743ascend-plus@ndph.ox.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomised double-blind placebo-controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised double-blind placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 1, 2022

Study Start

March 13, 2023

Primary Completion (Estimated)

August 17, 2028

Study Completion (Estimated)

August 17, 2048

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Proposals for substudies must be approved by the Steering Committee.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of results
Access Criteria
Procedures for accessing the data for this study are available on: https://www.ndph.ox.ac.uk/data-access
More information

Locations

GB(1)