Type II Diabetes Mellitus
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Confirmed diagnosis of T2DM by standard criteria. • Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (= 1500 mg) as monotherapy and in combination with SU, TZDs, and glinides at visit 1 with: • Monotherapy HbA1c = 8.5 and = 11.0% • Dual therapy HbA1c = 7.5% and = 11.0% • Age: =18 to = 78years at Visit 1. • HbA1c of = 7.5 and = 11.0% at Visit 105, • Body Mass Index (BMI) =22 to =45 kg/m2 at Visit 1. • Patients not already treated with glimepiride must be willing to switch to that drug. 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: • FPG = 270 mg/dL (= 15.0 mmol/L) at Visit 1 and at Visit 105 (Week -1). • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. • Use of weight control products including weight-loss medications • DPP-4 inhibitors, GLP-1 analogues/mimetics or insulin within the previous 6 months • Chronic oral (>7 consecutive days), parenteral or intra-articular corticosteroid treatment within 8 weeks • Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g., Cushing’s syndrome or acromegaly-associated diabetes). • Hepatic disorders • Clinically significant renal dysfunction • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1 or Visit 105 (Week -1), confirmed by repeat measure within 3 working days • Total bilirubin > 2 x ULN and/or direct bilirubin > ULN at Visit 1 or Visit 105 (Visit -1), confirmed by repeat measure within 3 working days • Positive Hepatitis B surface antigen (HbsAg) at Visit 1 • Positive Hepatitis C antibody test (anti-HCV) at Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the efficacy of add-on therapy with vildagliptin 50 mg bid to metformin and glimepiride in patients with T2DM by testing the hypothesis that the HbA1c reduction with vildagliptin 50 mg bid is superior to that with placebo added to metformin and glimepiride after 24 weeks of treatment.;Secondary Objective: • To demonstrate the efficacy of add-on therapy with vildagliptin 50 mg bid to metformin and glimepiride in patients with T2DM by testing the hypothesis that the FPG reduction with vildagliptin 50 mg bid is superior to that with placebo after 24 weeks of treatment. • To evaluate the safety and tolerability of vildagliptin as add-on therapy to metformin and glimepiride in patients with type 2 diabetes inadequately controlled with combination of metformin and glimepiride as compared to placebo after 24-week treatment. • To evaluate the responder rate of vildagliptin 50 mg bid as add-on therapy to metformin and glimepiride in patients with type 2 diabetes, as compared to placebo after 24-week treatment ;Primary end point(s): primary efficacy variable : reduction in HbA1c | — |
Countries
Germany, Hungary, Italy, United Kingdom
Outcome results
None listed