Asian Diabetes Outcomes Prevention Trial
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
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
Treatments tested in this trial
- Renin-angiotensin-aldosterone system inhibitors
- Beta blocker
- SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product
Treatment groups
2,400 Participants
are divided into 2 treatment groupsSponsors and collaborators
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