Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in Type 2 Diabetes
- Registration Number
- NCT01357252
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in the treatment of type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 279
Inclusion Criteria
- Confirmed diagnosis of T2DM by standard criteria
- Patients who have received a stable dose of SU for at least 12 weeks prior to Visit 1
- HbA1c ≥7.5% to ≤ 11.0% at Visit 1 and Visit 3 (Week -1)
- Age: ≥18 to ≤ 80 years at Visit 1.
- BMI ≥ 20 and ≤ 40 kg/m^2 at visit 1.
Exclusion Criteria
- FPG ≥ 270mg/dl (15.0 mmol/L) at Visit 1 or Visit 3 (Week -1)
- Severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between Visit 2 and Visit 4)
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo - vildagliptin vildagliptin -
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c 24 weeks
- Secondary Outcome Measures
Name Time Method Safety and tolerability (Frequency of adverse events, serious adverse events, and notable laboratory abnormalities) of add-on therapy with vildagliptin 50 mg qd to glimepiride as compared to pbo 24 weeks Change from baseline in Fasting Plasma Glucose 24 weeks Responder rates - proportion of subjects reaching predefined HbA1c targets 24 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇳Shanghai, China