Intervention for High-normal or Borderline-elevated Blood Pressure in Adults With Type 2 Diabetes "IPAD"

Not yet recruiting

Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- irrespective of sex;
- aged between 35 and 75 years;
- with office-measured seated BP 130-149 mm Hg systolic and below 90 mm Hg diastolic;
- without previous use of antihypertensive drugs;
- diagnosed of type 2 diabetes mellitus (T2DM), with stable diabetic therapy (dose of any one antidiabetic drug has not changed by more than two-fold and new agents have not been added within the previous 3 months)
- a glycosylated hemoglobin (HbA1c) between 6.5% and 8.0%;
- informed consent provided and long-term follow-up possible

Exclusion Criteria

- a history of hypoglycemic coma / seizure within last 12 months;
- confirmed diagnosis of type 1 diabetes mellitus;
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over two times the upper limit of normal;
- serum creatinine >150 ╬╝mol/L;
- a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) > 30 mg/g;
- coronary artery disease requiring beta-blockers, renin-angiotensin system (RAS) blockers for secondary prevention within one year prior to randomization;
- congestive heart failure requiring treatment with digitalis, diuretics, beta-blockers, aldosterone antagonists, RAS blockers, and/or vasodilators within one year prior to randomization;
- acute on-set of myocardial infarction, heart failure or stroke within 6 months prior to randomization;
- a history of psychological or mental disorder;
- severe non-cardiovascular diseases that are life threatening, potentially limit follow-up to less than the projected duration (3 years);
- pregnancy or currently planning to have babies or lactation;
- known contraindications for the active study medications;
- a malignancy that clinical investigators consider as unsuitable to participate;
- any organ transplant;
- currently participating in another clinical trial.