Patients affected by type 2 diabetes mellitus (HbA1c&
Conditions
Interventions
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Tablet
INN or Proposed INN: Glibenclamide
Concentration unit:
Sponsors
Prof. Ivana Zavaroni
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 into the study. Are the trial subjects under 18? no Number of subjects for this age range: 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. Age below 35 years 2. Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.) 3. HbA1c 1.5 mg/dL, severe respiratory failure, etc.; 11. Contraindications to the use of a Sulfonylurea; 12. Contraindications to the use of a DPP-IV Inhibitor; 13. Laboratory findings, or other disease conditions, at the screening visit that might interfere with study measurements: a. Hemoglobinopathy known to affect HbA1c assays; b. Known chronic liver diseases, including HBV and HCV infection; c. Liver makers (AST, ALT, ALP, GGT, bilirubin) above 2 times the upper normal limit; d. Amylase above 2 times the upper normal limit; 14. Chronic use of systemic corticosteroids; 15. History of low compliance, clinically-relevant psychiatric disorders or any current/ historical finding suggesting the patient as inappropriate to follow the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess a superior efficacy and durability of the DPP-IV inhibitor Vildagliptin as an add-on treatment to Metforminin in comparison to Glibenclamide in terms of achievement and maintenance of a good glycemic control (HbA1c < 7%) in type 2 diabetic patients in failure with Metformin as monotherapy over a period of 36 months;Secondary Objective: -Primary objective measured at the end of follow-up(including Extension Phase),measured as % of patient developing primary or secondary failure with the association of Metformin plus one of the two experimental treatments(Glibenclamide or Vildagliptin-Absolute change of HbA1c on the short-term(month 4,V2)and long-term(month 36,V12)compared to randomization(V0)-Percent of patients achieving HbA1c goal(<7%)on the short-term(month 4,V2)-Percent of patients developing secondary failure(defined as HbA1c &#8805;7% from V4 to the end of the experimental period)among the ones who achieve HbA1c < 7% within 8 months(V3-Time on months from the first treatment dose to the occurrence of treatment failure based on the definition used for primary end-point determination-Absolute and percent change in body weight at 36 months(V12)compared to randomization(V0)-Long-term safety and tolerability as total number and type of adverse events-Long-term change in insulin secretion;Primary end point(s): Percent of patient developing primary or secondary failure with the association of Metformin plus one of the two experimental treatments (Glibenclimide or Vildagliptin). Primary failure is defined as HbA1c &#8805; 8% at V2 (four months of follow-up) or HbA1c &#8805; 7% at V3 (eight months of follow-up). Secondary failure is defined as HbA1c &#8805; 7% after V3 (from V4 to V12 included). | — |
Countries
Italy
Outcome results
None listed