E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10012601 |
E.1.2 | Term | Diabetes mellitus |
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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 |
To asses the effect of 6-month therapy with acetylcarnitine compared to placebo on systolic blood pressure in 228 patients with type 2 diabetes, arterial hypertension and dyslipidemia on stable background antihypertensive, hypoglycemic, and lipid lowering therapy. |
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E.2.2 | Secondary objectives of the trial |
To asses the effect of treatment on: - diastolic and pulse pressure - 24-h blood pressure profile (in a representative subgroup) - serum triglycerides and apolipoprotein(a) - glucose disposal rate (by euglycemic hyperinsulinemic clamp in a representative subgroup) - HOMA index, serum insulin, leptin, adiponectin (pending on the findings on the other efficacy variables) - blood glucose, serum cholesterol (Total and HDL), non-esterified fatty acids (NEFA), lypoproteins A and and uric acid - 2-hour post oral load blood glucose profile - high sensity C-reactive protein (hsCRP) and serum tumour necrosis factor (TNF) - urinary albumin excretion and estimated creatinine clearance - Glomerular filtration rate (GFR) and renal plasma flow (RPF), as assessed by iohexol and PAH plasma clearance, respectively, in a representative subgroup - need for concomitant therapy with antihypertensive, hypoglycemic, and lipid lowering agents To assess whether the observed changes in |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males and females >40 years old; - High-risk subjects with type 2 diabetes (WHO criteria); - High blood pressure (systolic blood pressure >140 mmHg or with concomitant antihypertensive treatment stable since at least 3 months); - Serum creatinine concentration <1.5 mg/dl;- Patients legally able to give written informed consent to the trial (signed and dated by the patient); - Written informed consent. |
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E.4 | Principal exclusion criteria |
- Uncontrolled diabetes (glycated hemoglobin >11%); - Acute cardiovascular events over the last 3 months; - Specific contraindications or history of hypersensitivity to the study drugs; - Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer; - Drug or alcohol abuse; - Any chronic clinical conditions that may affect completion of the trial or confound data interpretation; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial; - Evidence of an uncooperative attitude; - Any evidence that patient will not be able to complete the trial follow-up. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
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
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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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |