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

  • STATUS
    Recruiting
  • End date
    Sep 26, 2025
  • participants needed
    11414
  • sponsor
    XueQing Yu
Updated on 26 March 2022
diabetes
hypertension
calcium
stroke
type 2 diabetes mellitus
hba1c
hydrochlorothiazide
angiotensin
hemoglobin a1c
glycosylated hemoglobin
antihypertensive drugs
amlodipine 5 mg
type 1 diabetes mellitus
antidiabetic agents
antidiabetic drug

Summary

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.

Description

The IPAD trial is a randomized, open-label, parallel-designed, multicenter study. 11,414 patients will be recruited in three years with a median follow up of four years. IPAD tests the hypothesis that intensive antihypertensive medical therapy in adult patients with type 2 diabetes, whose seated BP ranges from 120 to 139 mm Hg systolic and < 90 mm Hg diastolic, results in 20% reduction in the incidence of major adverse cardiovascular and cerebrovascular events (the primary endpoint), a composite of stroke, cardiovascular death, nonfatal myocardial infarction (MI), hospitalization for heart failure (HF) and hospitalization for unstable angina. Secondary endpoints of this study include: stroke; cardiovascular death; MI; hospitalization for HF; hospitalization for unstable angina; all-cause mortality; overt albuminuria; worsened renal function (the estimated glomerular filtration rate decreased by > 30% from baseline); end-stage renal disease; development of diabetic retinopathy that needs interventional operation; peripheral arterial diseases; new on-set atrial fibrillation or flutter; cancer; decline of health-related quality of life. Inclusion criteria for the study include T2DM patients aged between 45 and 79 years within the aforementioned BP ranges. for participants in the intensive group, the sitting systolic BP should decrease to < 120 mm Hg, using titration and combination of study medications consisting of an angiotensin type-1 receptor blocker Allisartan (240 mg/day) and 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. Across the whole study, 820 primary endpoints are expected to occur. Interim analyses will be carried out on an intention-to-treat basis. At the completion of the trial, both an intention-to-treat and a per-protocol analysis will be performed.

Details
Condition Diabetes Mellitus, Type 2, Adverse Event, Blood Pressure, Prehypertension, Cardiovascular Risk Factor
Treatment Hydrochlorothiazide 25 mg, Amlodipine 5mg, Allisartan Isoproxil, Allisartan Isoproxil placebo, Amlodipine placebo, Hydrochlorothiazide placebo, Standard treatment by current guideline
Clinical Study IdentifierNCT03264352
SponsorXueQing Yu
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
a history of psychological or mental disorder
pregnancy or currently planning to have babies or lactation
severe diseases such as severe heart diseases
known contraindications for the active study medications
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
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