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Recruiting Phase 4

Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes

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About this study

Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.

Condition
Diabetes Mellitus, Type 2, Adverse Event, Blood Pressure, Prehypertension, Cardiovascular Risk Factor
Tested
Allisartan Isoproxil, Amlodipine 5mg, Standard treatment by current guideline
Sponsor
XueQing Yu

Who can join

Age
45 to 79 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 45 years
  • Maximum age: 79 years
  • Study condition: Diabetes Mellitus, Type 2, Adverse Event, Blood Pressure, Prehypertension, Cardiovascular Risk Factor
  • irrespective of sex;
  • aged between 45 and 79 years;
  • with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;
  • diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;
  • informed consent provided and long-term follow-up possible

Exclusion 17

  • poor control of blood glucose, HbA1c \> 10.0%
  • administration of any antihypertensive medications within 1 month;
  • a history of hypoglycemic coma / seizure;
  • confirmed diagnosis of type 1 diabetes mellitus;
  • alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
  • estimated glomerular filtration rate \< 45 ml/min/1.73m2;
  • a history of congestive heart failure with left ventricular ejection fraction \< 40%;
  • coronary artery disease requiring RAS blockers for secondary prevention;
  • acute on-set of stroke within 6 months prior to randomization;
  • a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g;
  • known contraindications for the active study medications;
  • a history of psychological or mental disorder;
  • pregnancy or currently planning to have babies or lactation;
  • severe diseases such as severe heart diseases;
  • an expected residual life span less than 3 years;
  • a malignancy that clinical investigators consider as unsuitable to participate;
  • currently participating in another clinical trial.

Where

1 site, 1 recruiting

Guangdong General Hospital

Guangzhou, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.