Diabetes MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Trade Name: ZIBREN
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Acetylcarnitine
Concentration unit: mg milligram(s)
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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;Primary end point(s): Systolic pressure | — |
Countries
Italy
Outcome results
None listed