E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
men and women with type 2 diabetes and persistent microalbuminuria |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061835 |
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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 |
The objective of this study is to determine the safety and efficacy of sulodexide in the treatment of patients with type 2 diabetes and persistent microalbuminuria, despite being treated with a maximum approved dose of an angiotensin II receptor blocker ARB or angiotensin-converting enzyme inhibitor ACEI . The primary efficacy measure will be the percentage of patients achieving therapeutic success, which is defined as a composite binary endpoint of conversion from microalbuminuria to normoalbuminuria ACR 25 mg/g 2.8 mg/mmol for men and ACR 35 mg/g 4.0 mg/mmol for women and at least a 25 reduction in ACR level relative to baseline at Week 26 or a 50 reduction in ACR level relative to baseline at Week 26. |
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E.2.2 | Secondary objectives of the trial |
The secondary efficacy measures will include percentage of patients achieving normoalbuminuria at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 4 and 8 weeks off therapy, respectively ; percentage of patients achieving 50 reduction in ACR from baseline at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 4 and 8 weeks off therapy, respectively ; observed ACR, and change from baseline in ACR at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 4 and 8 weeks off therapy, respectively ; percentage of patients reaching an ACR 61619;200 mg/g 22.6 mg/mmol at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 4 and 8 weeks off therapy, respectively ; and percentage change from baseline on various additional endpoints, including serum creatinine, Modification of Diet in Renal Disease MDRD estimated glomerular filtration rate GFR , and serum albumin. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
men and women with type 2 diabetes and persistent microalbuminuria in men urine albumin creatinine ratio ACR 35 200 mg albumin/g creatinine 4.0 - 22.6 mg/mmol , in women urine ACR 45 200 mg albumin/g creatinine 5.1 22.6 mg/mmol based on the geometric mean of 3 first voided AM urine samples at the qualifying visit Visit 6 will be randomized. Patient s serum creatinine must be less than or equal to 1.5 mg/dL at screening. |
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E.4 | Principal exclusion criteria |
1. Age of onset of type 2 diabetes 18 years; 2. HbA1C 10.0 ; 3. Morbid obesity defined as a body mass index BMI more than or equal to 45 kg/m2; 4. Type 1 insulin-dependent; juvenile onset diabetes; 5. patients with known non-diabetic renal disease, Renal allograft; 6. Absolute requirement for combination therapy of ACEI and ARB; 7. Cardiovascular disease 8. Need for chronic 2 weeks immunosuppressive therapy, 9. cancer 10. Inability to remain on a stable dose of the following class of medications 30 days prior to randomization and throughout the study 3-hydroxy-3-methylglutaryl-coenzyme A HMG-CoA reductase inhibitors statins ; Peroxisome proliferator-activated receptor gamma PPAR 61543; 61481; inhibitors glitazones ; Cyclooxygenase-2 inhibitors COX-2 inhibitors ; or Non-steroidal anti-inflammatory drugs NSAIDS ; 11. Known human immunodeficiency virus HIV disease; 12. Evidence of hepatic dysfunction including total bilirubin 2.0 mg/dL or liver transaminase AST or ALT 3 times upper limit of normal; 13. Untreated urinary tract infection |
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E.5 End points |
E.5.1 | Primary end point(s) |
Patients assigned to sulodexide 200 mg will achieve a significantly higher fraction of patient with therapeutic success at week 26, as defined by the composite binary endpoint of conversion from microalbuminuria to normoalbuminuria ACR 25mg/g for men and ACR 35mg/g for women and at least a 25 reduction in ACR level relative to baseline at week 26 or a 50 reduction in ACR level relative to baseline at week 26. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |