Preventing heart disease in high-risk diabetes patients
Asian Diabetes Outcomes Prevention Trial
This study is testing whether stronger medication for adults with type 2 diabetes and high heart disease risk can help prevent heart problems compared to regular treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2400 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | National Heart Centre Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04286399 on ClinicalTrials.gov |
What this trial studies
This trial aims to identify adults with type 2 diabetes who are at high risk for cardiovascular disease based on elevated NT-proBNP levels. It will test whether intensifying therapy with specific medications, including renin-angiotensin system inhibitors, beta-blockers, and SGLT2 inhibitors, can reduce cardiovascular events compared to standard care. The study will be conducted across five Asian regions, involving approximately 2,400 patients followed for two years. Participants must be at least 40 years old and have no known cardiovascular disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with type 2 diabetes and elevated NT-proBNP levels without known cardiovascular disease.
Not a fit: Patients with a history of cardiovascular disease or those who are already on maximum doses of the study medications may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cardiovascular events in high-risk diabetic patients.
How similar studies have performed: Other studies have shown promising results with similar therapeutic approaches in high-risk diabetic populations, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore
- Singapore General Hospital (SGH) — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Serene Ng Miss
- Email: serene.ng.b.l@singhealth.com.sg
- Phone: 67042232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.