Multi-center, randomized, open-label, two-parallel arm, intervention trial comparing DPP-IV inhibitor Vildagliptin with Glibenclamide (Glyburide) in achieving and maintaining good blood glucose control in type 2 diabetic patients in treatment failure with Metformin alone - Long-term clinical effectiveness of DPP-IV inhibitors
- Conditions
- Patients affected by type 2 diabetes mellitus (HbA1c&MedDRA version: 9.1Level: HLTClassification code 10012602#88057%)treated with Metformin alone
- Registration Number
- EUCTR2009-014727-23-IT
- Lead Sponsor
- Prof. Ivana Zavaroni
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
1. Age below 35 years 2. Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.) 3. HbA1c < 7% or ≥ 10% at the screening visit 4. Treatment with any blood glucose lowering treatment other than Metformin in the three months before screening visit 5. BMI < 20 or ≥ 40 kg/m2, or current/ past history of clinically-relevant eating disorders (including -but no limited to- nervous anorexia, bulimia, binge-eating disorder, etc.) 6. Significant progression of diabetic macro-angiopathy or cardiovascular disease in the six months prior to study visit, including: a. Acute myocardial infarction or acute coronary syndrome requiring hospitalization; b. Acute cerebro-vascular event requiring hospitalization; c. Acute limb ischemia or new onset of clinically-relevant peripheral artery disease (as defined by claudication + positive ABI test); d. New limb ulceration of suspected vascular origin or new onset of a diabetic foot or significant progression of pre-existing lesions; e. Any revascularization procedure (by-pass, stenting, angioplasthy, trombo-endarterectomy, etc.) in any arterial district; 7. Significant progression of diabetic micro-angiopathy in the six months prior to study visit, including: a. Proliferative retinopathy, or progression of severity of more than one step, or new macular edema likely to be laser-treated. Steps of diabetic retinopathy: absent, background, mild non-proliferative, moderate-to-severe non-proliferative, proliferative; b. Increase of at least 0.5 mg/dL of plasma creatinine or progression to macro-proteinuria; c. Onset of clinically-relevant neuropathy d. Onset of erectile dysfunction 8. Organ failure or other severe diseases limiting life expectancy; 9. Ongoing pregnancy or absence of effective contraception in women with childbearing potential 10. 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.; 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method