E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The population for this study includes women and men with type 2 diabetes and clinically overt proteinuria. |
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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 efficacy of sulodexide in reducing the rate of progression of renal disease and adverse clinical sequelae in patients with diabetic nephropathy due to type 2 diabetes. |
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E.2.2 | Secondary objectives of the trial |
The secondary outcome measures will include individual analyses of the frequency in doubling of the serum creatinine from baseline, time to ESRD, amount of change from baseline in PCR and albumin creatinine ratio ACR , and time to all-cause mortality. The tertiary outcome measure will consist of a composite endpoint of cardiovascular death, non-fatal myocardial infarction, hospitalization for congestive heart failure CHF , stroke, transient ischemic attack, resuscitated sudden death RSD , coronary revascularization procedure, and peripheral vascular procedure. Evaluation of the safety of sulodexide will be based upon the assessment of adverse events and clinically important changes in laboratory parameters. Particular attention will be given to those events which result in discontinuation of study medication or which are serious in nature. A DSMC will meet periodically to review unblinded safety and efficacy results throughout the trial. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The population for this study includes women and men with type 2 diabetes and clinically overt proteinuria protein creatinine ratio PCR the geometric mean of 3 AM first voided urine of 61619;900 mg/G 101.7 mg/mmol for women and 61619;650 mg/G 73.45 mg/mmol for men . In addition, serum creatinine in women must be between 1.3 and 3.0 mg/dL 115 265 956;mol/L , inclusive, and in men between 1.5 and 3.0 mg/dL 133-265 956;mol/L , inclusive. If the serum creatinine falls outside the specified creatinine criteria, a patient may enter the Run-in Period only if the glomerular filtration rate GFR is between 25 and 61472;45 mL/min, as calculated by the Modification of Diet in Renal Disease MDRD formula. |
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E.4 | Principal exclusion criteria |
Type I diabetes, known non-diabetic renal disease, renal allograft, need for a combination of ACEI and ARB, cardiovascular disease, need for chronic immunosuppressive treatement, cancer, HIV, evidence of hepatic disfunction, untreated urinary tract infection. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome measure will consist of a composite endpoint of a doubling of the serum creatinine from baseline or end-stage renal disease ESRD . ESRD is defined as renal transplantation, the need for dialysis, or a serum creatinine 61619;6.0 mg/dL 530 956;mol/L . |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |