Health TrialsbyHealthPanel

Asian Diabetes Outcomes Prevention Trial

ConditionsDiabetes MellitusCardiovascular Diseases
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorNational Heart Centre Singapore

About this trial

The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (\>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Type 2 diabetes for at least six months

≥ 40 years of age, men or women

No known cardiovascular disease ( defined as known coronary stenosis > 70%, reduced left ventricular ejection fraction < 40%, or a history of myocardial infarction/ coronary revascularization/ heart failure hospitalization/ stroke/ prior non-traumatic lower limb amputation or angioplasty)

NT-proBNP > 125 pg/mL

Disqualifiers

History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance

Patients already on a maximum dose of RAASi or beta-blocker

History of DM ketoacidosis/Type 1 DM

eGFR < 45ml/min/1.73m2

Trial design

Design model

Parallel

Treatments tested in this trial

  • Renin-angiotensin-aldosterone system inhibitors

    Drug

    Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.

  • Beta blocker

    Drug

    Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.

  • SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product

    Drug

    Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.

Treatment groups

2,400 Participants
are divided into 2 treatment groups
Group A: Intensive Treatment GroupOther 3 interventions
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Combined endpoint based on the first occurrence of cardiovascular death or major adverse cardiovascular event

Stroke/myocardial infarction/heart failures events

Time frame
48 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Heart Centre Singapore

Lead sponsor

Singapore General Hospital

Collaborator

Mackay Memorial Hospital

Collaborator

National Taiwan University Hospital

Collaborator

Peking University People's Hospital

Collaborator

Medanta, The Medicity, India

Collaborator

Public Health Foundation of India

Collaborator

Putrajaya Hospital, Malaysia

Collaborator

Universiti Teknologi Mara

Collaborator

Source ClinicalTrials.gov
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