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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
279
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Change from baseline in HbA1c
Time frame: 24 weeks
Change from baseline in Fasting Plasma Glucose
Time frame: 24 weeks
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
Time frame: 24 weeks
Responder rates - proportion of subjects reaching predefined HbA1c targets
Time frame: 24 weeks
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Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Zhenjiang, Jiangsu, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, China
...and 8 more locations