The effects of the association bindarit + irbesartan versus irbesartan alone on albuminuria of patients with Diabetic Nephropathy. Double-blind placebo-controlled study followed by an open extension phase.

Phase 1

• Conditions: Diabetic Nephropathy (Type 2 diabetes); MedDRA version: 9.1Level: LLTClassification code 10061835Term: Diabetic nephropathy

• Registration Number: EUCTR2006-006191-38-SI
• Lead Sponsor: Angelini Farmaceutici, ACRAF S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-04
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

male and female 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 µg/min in at least 2 of 3 overnight urine samples or macroalbuminuria defined as urinary albumin excretion, > 200 µg/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% at Screening [Brenner 2000]; • serum creatinine = 3 mg/dL at Screening; • 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; • patients legally able to give 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

patients hypersensitive or allergic to ARBs or bindarit or its components, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of the study is to compare the reduction of UAE between treatment groups in patients with type 2 diabetes and micro- or macroalbuminuria.;Secondary Objective: Secondary objectives are 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 within treatment groups; v) to evaluate the comparative safety and tolerability of bindarit in association with irbesartan.;Primary end point(s): The primary efficacy endpoint is the UAE rate measured in overnight samples. The patient UAE levels will be assessed at each visit in comparison to the baseline value.