Patients with type II diabetes with nephropathy MedDRA version: 9.1 Level: SOC Classification code 10047065 Term: Vascular disorders
Conditions
Sponsors
ANGELINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be enrolled under the following circumstances males and females patients with no limitation of race, aged 30 to 70 years; Type 2 diabetes defined as 30 years of age at diagnosis; insulin not required within 6 months of initial diagnosis; no history of diabetic ketoacidosis; currently treated with diet, oral hypoglycemics or insulin Brenner 2000 ; microalbuminuria defined as urinary albumin excretion, 20 to 200 g/min in at least 2 of 3 overnight urine samples or macroalbuminuria defined as urinary albumin excretion, 200 g/min in at least 2 of 3 overnight urine samples, confirmed in the baseline collection; should baseline albuminuria data not to be available, the patient may be conditionally treated; glycosylated haemoglobin Hb A1c 12 Brenner 2000 ; serum creatinine 8804; 3 mg/dL; normotensive patients or hypertensive patients on stable antihypertensive therapy over the last 3 months and without specific contraindications to angiotensin antagonist therapy; female patients of childbearing potential required to have a negative pregnancy test and use an approved birth control method; written informed consent to the trial signed and dated by the patient. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients cannot enter the trial under the following circumstances patients hypersensitive or allergic to ARBs, or with a positive history for drug allergy; Type 1 diabetes Brenner 2000 ; history of non diabetic renal disease, including renal artery stenosis Brenner 2000 ; history of heart failure before enrolment Brenner 2000 ; acute myocardial infarction, coronary artery bypass grafting within the past one month Brenner 2000 ; cerebral vascular accident or coronary angioplasty within the past six months month Brenner 2000 ; Transient Ischemic Attacks TIA in the past 12 months Brenner 2000 ; primary aldosteronism or pheocromocytoma Brenner 2000 ; severe uncontrolled hypertension sitting diastolic blood pressure 115 and/or sitting systolic blood pressure 220 mm Hg in the previous 6 months; chronic use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressive drugs, MAO inhibitors; patients under the influence of alcohol or narcotics; patients treated with experimental drugs in the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary to compare the reduction of albuminuria between treatment groups in patients with type 2 diabetes and micro- or macroalbuminuria;Secondary Objective: Secondary i to compare the MCP-1 urinary levels between treatment groups, ii to compare the rate of remission from micro- to normo- and from macro- to microalbuminurua in the two treatment group; iii to correlate the MCP-1 urinary levels and UAE within treatment groups iv to detect any relationship between degree of UAE reduction and serum lipids profile within treatment groups; v to evaluate the comparative safety and tolerability of bindarit in association with irbesartan;Primary end point(s): Primary to compare the reduction of albuminuria between treatment groups in patients with type 2 diabetes and micro- or macroalbuminuria | — |
Countries
Italy
Outcome results
None listed