Asian Diabetes Outcomes Prevention Trial

Summary

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

Inclusion Criteria:

* 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
* Written informed consent

Exclusion Criteria:

* 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
* Symptomatic hypotension and/or Visit 1 systolic blood pressure (SBP) \< 100mmHg.
* Symptomatic bradycardia, high-grade AV blocks (Grade 2 and 3) and/or Visit 1 heart rate (HR) \< 60bpm.
* Any disease other than diabetes lowering the patient's life expectancy to less than two years.
* Chronic infections (E.g. chronic cystitis, recurrent urinary tract infections) or malignancies or uncontrolled thyroid disorder or liver disease
* Systemic treatment with corticosteroids.
* Pregnant or nursing women
* Any other clinical condition that might affect patients' safety during trial, at the investigator's discretion.
* Participation in an investigational drug trial

Conditions3

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