NCT04286399 Asian Diabetes Outcomes Prevention Trial
| NCT ID | NCT04286399 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Heart Centre Singapore |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2019-07-01 |
| Primary Completion | 2022-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,400 participants in total. It began in 2019-07-01 with a primary completion date of 2022-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Carolyn Lam Prof
STUDY DIRECTOR
National Heart Centre Singapore
Frequently Asked Questions
Who can join the NCT04286399 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04286399 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04286399 currently recruiting?
Yes, NCT04286399 is actively recruiting participants. Contact the research team at serene.ng.b.l@singhealth.com.sg for enrollment information.
Where is the NCT04286399 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT04286399 clinical trial?
NCT04286399 is sponsored by National Heart Centre Singapore. The principal investigator is Carolyn Lam Prof at National Heart Centre Singapore. The trial plans to enroll 2,400 participants.
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