type 2 diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10012614 Term: Diabetes mellitus NOS System Organ Class: 100000004861
Conditions
Interventions
Trade Name: GALVUS*56CPR 50MG
Pharmaceutical Form: Tablet
INN or Proposed INN: VILDAGLIPTIN
CAS Number: 274901-16-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age equal or above 35 years; 2. Diagnosis of type 2 diabetes mellitus as defined by the American Diabetes Association , with at least one year of disease duration at the time of the screening visit; 3. Blood glucose lowering treatment with Metformin alone (monotherapy) at a stable dose of at least 1.5 g/day (or maximum tolerated dose) in the 3 months prior to the screening visit; 4. Insufficient metabolic control as defined by recent (last six months) HbA1c = 7% in any peripheral laboratory and confirmed at the time of the screening; 5. Absence of a recent clinically-relevant progression of micro- and macro-vascular complications (see exclusion criteria); 6. Written informed consent to participate to 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Age below 35 years 2. Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.) 3. HbA1c 190 or DBP >100 mmHg) 14. Ongoing pregnancy or absence of effective contraception in women with childbearing potential 15. Contraindications to the maintenance of the background therapy (Metformin), including –but not limited to- chronic kidney failure or plasma creatinine concentrations > 1.5 mg/dL, severe respiratory failure, etc.; 16. Contraindications to the use of a Sulfonylurea; 17. Contraindications to the use of a DPP-IV Inhibitor; 18. Laboratory findings, or other disease conditions, at the screening visit that might interfere with study measurements: - Hemoglobinopathy known to affect HbA1c assays; - Known chronic liver diseases, including HBV and HCV infection; - Liver makers (AST, ALT, ALP, GGT, bilirubin) above 2 times the upper normal limit; - Amylase and/or lipase above 2 times the upper normal limit; 19. Chronic use of systemic and/or inhaled corticosteroids (only topical corticosteroids are allowed); 20. History of low compliance, clinically-relevant psychiatric disorders or any current/ historical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of DPP-IV inhibitor Vildagliptin vs. Glibenclamide on circulating EPCs.;Secondary Objective: Absolute and relative change in HbA1C at visit V2, V3, V4.;Primary end point(s): Absolute and relative change in the EPC number at visit: V0 (randomization), V2 (month 4), V3 (month 8) and V4 (month 12).;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Absolute and relative change in HbA1C at visit V2, V3, V4.;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactComitato Etico Unico
Segreteria Scientifica Comitato Etico
Outcome results
None listed