Lowering Blood Pressure in Adults With Type 2 Diabetes

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

This study is testing if lowering blood pressure to below 120 mm Hg with a combination of medications can help adults with type 2 diabetes avoid serious heart and brain problems.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11414 (estimated)
• Ages: 45 Years to 79 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT03264352 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of intensive antihypertensive treatment in adults with type 2 diabetes who have high-normal blood pressure. It is a randomized, open-label, parallel-designed, multicenter study aiming to recruit nearly 12,000 patients over three years, with a median follow-up of four years. The primary goal is to determine if lowering systolic blood pressure to below 120 mm Hg can reduce the incidence of major cardiovascular and cerebrovascular events by 20%. Participants will receive a combination of medications including Allisartan and Amlodipine to achieve these targets.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 to 79 years with type 2 diabetes and seated blood pressure between 120-139 mm Hg systolic and below 90 mm Hg diastolic.

Not a fit: Patients with poorly controlled blood glucose, severe renal impairment, or a history of certain cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of serious cardiovascular events in patients with type 2 diabetes and high-normal blood pressure.

How similar studies have performed: Other studies have shown that lowering blood pressure in hypertensive individuals with diabetes can lead to improved cardiovascular outcomes, suggesting this approach is promising.

Eligibility criteria

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;
* 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 this trial is running

Guangzhou, Guangdong

• Guangdong General Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Jiyan Chen, MD — Guangdong Provincial People's Hospital
• Study coordinator: Jiyan Chen, MD

Conditions Diabetes Mellitus, Type 2; Adverse Event; Blood Pressure; Prehypertension; Cardiovascular Risk Factor