patients with type 2 diabetes poorly controlled MedDRA version: 14.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration number: 100-
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration number: 100-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA' DEGLI STUDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. type 2 diabetic patients on metformin therapy without adequate glycemic control (within 3 months) (HbA1c >7.5%) while on hypocaloric diet regiment for almost three months. 2. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 3. Female patients who are receiving nonyclical hormone therapy (including non cyclical hormone replacement therapy or any estrogen antagonist/agonist) have been maintained on a stable dose and regimen for at least 8 weeks prior to Visit 1 and patient is willing to continue the same regimen throughout the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. BMI >35 kg/m2. 2. Patient having hypersensitivity or intolerance to vildagliptin and sitagliptin or any component of these medications. 3. Patient routinely consuming more than 3 alcoholic drinks per day. 4. Patient currently participating in a study with an investigational compound 5. Patient's glycemia are >300 mg/dL at Visit 2. 6. Patient with uncontrolled endocrine or metabolic disease known to influence glycemia (i.e., secondary causes of hyperglycemia). 7. Patient with NYHA class III /IV 8.Unstable Angina pectoris, with precedent history of heart attack and bypass or angioplastica or severe peripheral arteriopatia. 9. ileale bypass partial , gastric bypass or intestinal illness 10. hypertension , with systolic PA > 160 mm Hg or diastolic > 100 mm Hg to the visit 1. 11. Presence of filtrate glomerulare (eGFR) < 30 mL / min /1.73 m2s, with syndrome nefrosica or other renal illnesses. 12. Hematological pathologies. 13. Cerebrovascular pathologies, included the cognitive deficits e/o psychiatric pathologies that limit the ability to participate in the study. 14. Positiveness to the HIV. 15. neoplasie History in the 5 preceding years to the date of the informed consent. 16. illegitimate drugs use or recent history of alcoholism in the last year. 17. Use of the citocrome P450 3A4 (CYP3A4)inhibitors. 18. Use of ciclosporine, danazolo or sour fusidico 19. Treatment with corticosteroidi (ev or im) 20. Treatment with Orlistat or sibutramine 21. Treatment with warfarin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the respective effects of vildagliptin and sitagliptin, as a regulation strategy attempting to stabilize glucose excursions over 24 hours, on oxidative stress and proinflammatory cytokines implicated in the atherosclerotic process, in patients with type 2 diabetes poorly controlled with metformin therapy.;Secondary Objective: none;Primary end point(s): nitrotyrosine and proinflammatory cytokines reduction | — |
Countries
Italy
Outcome results
None listed