Diabetic nephropathy MedDRA version: 6.1 Level: PT Classification code 10061835
Conditions
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Males and females 40 years old; -High-risk subjects with type 2 diabetes WHO criteria ; -History of diabetes not exceeding 25 years; -High blood pressure systolic and/or diastolic blood pressure 135/85 mmHg or concomitant treatment with blood pressure lowering medications ; -Serum creatinine concentration 1.5 mg/dl; -Overnight urinary albumin excretion in at least 2 of 3 consecutive overnight urine collections 10 and 20 g/min; -Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Uncontrolled diabetes glycated hemoglobin 11 ; -Specific contraindications or history of hypersensitivity to the study drugs; -Serum potassium 8805; 5.5 mEq/L despite diuretic therapy, and optimized metabolic and acid/base control; -Bilateral renal artery stenosis; -Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer; -Drug or alcohol abuse; -Any chronic clinical conditions that may affect completion of the trial or confound data interpretation; -Pregnancy or lactating; -Women of childbearing potential without following a scientifically accepted form of contraception; -Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial; -Evidence of an uncooperative attitude; -Any evidence that patient will not be able to complete the trial follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Development of persistent microalbuminuria i.e. urinary albumin excretion rate 20 g/min in at least 2 of 3 consecutive overnight urine collections confirmed in two consecutive visits . Whenever a patient will be found to have 2 of 3 collections in the microalbuminuric range, he will be asked to submit 3 additional consecutive collections within 2 months. If urinary albumin excretion rate is still 20 g/min in at least 2 of 3 samples, he will be considered to be microalbuminuric and to have reached the end point.;Main Objective: To evaluate whether, at comparable blood pressure control, dual RAS blockade with combined therapy with halved doses of benazepril 10 mg/day and valsartan 160 mg/day reduces the incidence of microalbuminuria more effectively than single drug RAS blockade by full doses of benazepril 20 mg/day or valsartan 320 mg/day given alone in high-risk patients with type 2 diabetes, hypertension and high normal albuminuria.;Secondary Objective: - To evaluate whether, at comparable blood pressure control, the effects of benazepril and valsartan therapy are similar or whether, alternatively, one of the two treatments offer a superior protective effect against the development of microalbuminuria in the above study population. - To evaluate the effects of the three study treatments on the incidence of fatal and non-fatal cardiovascular events, regression to low-normal albuminuria urinary albumin excretion 10 g/min , albuminuria considered as a continuous variable , serum creatinine, lipid profile, and GFR in a representative subgroup ; - To assess the relationships, in the study group as a whole and within each treatment group, between renal outcome variables including microalbuminuria and time-dependent changes in albuminuria and fatal and non-fatal cardiovascular events, between achieved blood pressure or metabolic control and renal and/or cardiovascular outcome variables and between achieved albuminuria red | — |
Countries
Italy
Outcome results
None listed