A multi-center, randomized, double-blind placebo controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with type 2 diabetes
- Conditions
- Type II Diabetes Mellitus
- Registration Number
- EUCTR2010-021097-11-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 290
•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
•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
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