E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Nephropathy (Type 2 diabetes) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061835 |
E.1.2 | Term | Diabetic nephropathy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |