A multinational,randomized open-label,parallel-group, active-controlled,two-arm, long-term morbidity and mortality trial involving intensive preventive therapy (high dose renin-angiotensin-aldosterone system inhibitors [RAASi],beta-blockade,sodium-glucoseco-transporter 2
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/02/031350
- Lead Sponsor
- ational Heart Centre of Singapore Pte Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Type 2 diabetes for at least six months as defined by the American Diabetes Association Standards of
Medical Care in Diabetes 2019 criteria and/or receiving anti-diabetic therapy for the established diagnosis.
- Fasting plasma glucose greater than or equal to 126 mg/dL or 7.0 mmol per L. Fasting is defined as no caloric intake for at least 8hrs,
OR
- 2 hour postprandial glucose greater than or equal to 200 mg per dL or 11.1 mmol per L during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water,
OR
- A1C greater than or equal to 6.5 percentage 48 mmol per mol. The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay,
OR,
- In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose greater than or equal to 200mg per dL or 11.1 mmol per L in absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or in two separate test
samples
2. Greater than or equal to 40 years of age, men or women
3. No known cardiovascular disease defined as known coronary stenosis greater than 70%, reduced left ventricular ejection fraction less than 40%, or a history of myocardial infarction or coronary revascularization or heart failure hospitalization or stroke or prior non-traumatic lower limb amputation or angioplasty
4. NT proBNP greater than 100 pg per mL
5. Written informed consent
1. 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 to high dose of RAASi or beta-blocker in the absence of any other blood pressure lowering drugs
2. Patients already on a maximum dose of RAASi or beta-blocker
3. History of DM ketoacidosis or Type 1 DM
4. eGFR less than 430ml per min per 1.73m2. eGFR cut-off as per local approvals for SGLT2 inhibitor use. Results from clinical tests done within 6 months of the visit date can be used.
5. Symptomatic hypotension and/or Visit 1 systolic blood pressure SBP less than 100mmHg
6. Symptomatic bradycardia, high-grade AV blocks Grade 2 and 3 and or Visit 1 heart rate HR less than 60bpm.
7. Any disease other than diabetes lowering the patient’s life expectancy to less than two years
8. Chronic infections E.g. chronic cystitis, recurrent urinary tract infections or malignancies or uncontrolled thyroid disorder or liver disease
9. Systemic treatment with corticosteroids.
10. Pregnant or nursing women
11. Any other clinical condition that might affect patients safety during trial, at the investigators discretion
12. Participation in an investigational drug trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method