Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

Study Overview
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Brief Summary
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Hypertension is the most common complication in patients with diabetes nephropathy. Strengthening blood pressure and blood sugar control is the basic treatment for patients with diabetes nephropathy. Angiotensin receptor blocker (ARB) and angiotensin-converting enzyme inhibitor (ACEI) are the first line drugs recommended in domestic and international guidelines for diabetes patients to control hypertension. As a new ARB drug, azilsartan has been found to have better antihypertensive effect than other ARB drugs. However, due to the limited sample size and study time, azilsartan has no significant advantage over other ARB drugs in terms of renal protection effect, and has not been systematically studied in diabetes nephropathy population. This study is intended to evaluate the effect of azilsartan on proteinuria and blood pressure improvement in patients with diabetes nephropathy and hypertension through clinical randomized controlled study, so as to accumulate evidence-based evidence of azilsartan in the comprehensive management of heart and kidney protection in this group of people, and promote the development of comprehensive treatment for patients with metabolic disease and renal injury combined with hypertension. This study will compare the advantages and disadvantages of azilsartan and classical ARB drug losartan potassium in terms of proteinuria, blood pressure control and renal function protection in patients with diabetes nephropathy and hypertension; We propose that the main indicator is the change of urinary albumin/creatinine ratio relative to the baseline, and the secondary indicator is the change of 24-hour urinary protein relative to the baseline; Change of blood pressure relative to baseline; Renal function, electrolyte and blood glucose.

Official Title
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The Effect of Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

Conditions
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Proteinuria, Kidney Dysfunction, Blood Pressure, Diabetic Kidney Disease

Intervention / Treatment
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* Drug: Azilsartan
* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30 to 70; Type 2 diabetes diagnosed according to American Diabetes Association guidelines has stable blood sugar control, and glycosylated hemoglobin is less than 7.5%; The patient's blood pressure Systemic Blood Pressure (SBP) >140 or Diastolic Blood Pressure (DBP) >90 mmHg, has not taken antihypertensive drugs or is taking non-ARB/ACEI antihypertensive drugs; Urine albumin/creatinine ratio>300mg/g. Exclusion Criteria: Type 1 diabetes; The patient is considered as non-essential hypertension, such as hypertension caused by renal hypertension or endocrine disease; Contraindications of ARB drugs, such as pregnancy status, bilateral renal artery stenosis, allergy to ARB drugs and their excipients; It is expected that dialysis treatment will be carried out within 6 months; Patients with malignant tumors; Patients with mental illness; The researcher believes that others are not suitable for this study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: azilsartan group<br>the initial dose of azilsartan is 20mg/day, if not reached the goal of blood pressure, azilsartan was adjust to 40mg/day | Drug: Azilsartan<br>* Azilsartan initial dose 20mg/d, if not reached the goal of hypertension; azilsartan dose 40mg/d<br>|
| Active Comparator: losartan group<br>the initial dose of losartan is 40mg/day, if not reached the goal of blood pressure, losartan was adjust to 80mg/day | Drug: Losartan<br>* losartan initial dose 40mg/d, if not reached the goal of hypertension; losartan 100mg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteinuria | urinary protein | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour urine protein | 24 hour total protein | up to 16 weeks | 
| blood pressure | bp | up to 16 weeks | 
| kidney function | creatine, Blood Urine Nitrogen | up to 16 weeks | 
| urinary albumin/ creatine | urinary albumin/ creatine | up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic kidney disease, hypertension