Asian Diabetes Outcomes Prevention Trial (ADOPT)
Diabetes Mellitus, Cardiovascular Diseases
About this trial
This is an interventional treatment trial for Diabetes Mellitus
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
Sites / Locations
- Singapore General Hospital (SGH)Recruiting
Arms of the Study
Arm 1
Arm 2
Other
No Intervention
Intensive Treatment Group
Control Group
High dose of RAASi and beta-blockers (unless contraindicated) as well as preferential use of SGLT2i as per local drug label guidelines on top of standard therapy.
Standard therapy where the use of SGLT2i at randomization is not encouraged but RAASi and beta-blockers (except for maximal dosage) are allowed. Prescription or up-titration of the study drugs listed under Intensive Treatment is not encouraged. If investigators/treating physicians feel that further prescription or up-titration is required, a thorough justification is mandatory. Unless there is clinically irrefutable reason, every attempt should be made to use other blood pressure lowering drugs than RAASi or beta-blockers, as well as glucose lowering drugs than SGLT2i, in the control group.