Asian Diabetes Outcomes Prevention Trial

• Status: Recruiting
• Trial end date: 2034-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart Centre Singapore
• Collaborators: Mackay Memorial Hospital; Medanta, The Medicity, India; National Taiwan University Hospital; Peking University People's Hospital; Public Health Foundation of India; Putrajaya Hospital, Malaysia; Singapore General Hospital; Universiti Teknologi Mara
• Treatments: Adrenergic beta-Antagonists; Angiotensin II; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Sodium-Glucose Transporter 2 Inhibitors

Criteria

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