Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: intensive preventive therapy: Adults: NT-proBNP greater than 100 pg/mL
Study period: 2 years recruitment and 2 years follow-up.
Control Intervention1: Control group: Patients receive
Sponsors
National Heart Centre of Singapore Pte Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 30ml 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 patientâ??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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) All-cause death 2) First CV Hospitalization 3) CV elective and urgent visits 4) Kidney function a. UACR change b. Presence of CKD (eGFR less than 60 mL/min/1.73 m2) at 2 years c. Annualized eGFR slope 5) NT-proBNP % change from baseline to 1 year 6) HbA1c control at 2 years (defined at 7% threshold) 7) Blood pressure control at 2 years a. Defined at systolic blood pressure 120 mmHg threshold b. Defined at systolic blood pressure 130 mmHg thresholdTimepoint: Visit 1: Screening, Interim visits for the Intensive treatment group only, Visit 2 (3 months 1 week), Visit 3 (12 months 2 weeks), Visit 4 (24 months 2 weeks), Long-term follow-up (LTFU) (36 and 48 months 3 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: 1) Composite outcome of all-cause death or first CV hospitalization 2) Composite outcome of CV death or first CV hospitalization 3) Composite outcome of CV death or first major adverse cardiovascular event (stroke/ myocardial infarction/ heart failure events) 4) Health economic analysis (cost-effectiveness of intervention considering both life-years & quality of life adjusted life years) 5) Other predefined biomarkers (Section 4.2 on plasma/serum & urinary biomarkers) Safety assessment: 1) Systolic & diastolic BP 2) Heart rate 3) Laboratory values 4) Electrocardiography (ECG) 5) eGFR 6) UACR 7) HbA1c 8) Adverse events profile including hypo-/ hyperglycaemic events, genital infections/diabetic ketoacidosis/acute kidney injury/bone fractures 9) Non-traumatic lower limb amputations or lower limb angioplastyTimepoint: Visit 1: Screening, Interim visits for the Intensive treatment group only, Visit 2 (3 months 1 week), Visit 3 (12 months 2 weeks), Visit 4 (24 months 2 weeks), Long-term follow-up (LTFU) (36 & 48 months 3 weeks). | — |
Countries
China, India, Malaysia, Singapore, Taiwan, United Arab Emirates
Contacts
Public ContactDR VIJAY KUMAR CHOPRA
Max Super Speciality Hospital
Outcome results
None listed