This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
431
vildagliptin 50mg bid
Placebo 50mg bid
To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo
Time frame: 24 weeks
To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram.
Time frame: 24 weeks
To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo
Time frame: 24 weeks
To assess the responder rates of patients treated with vildagliptin as compared to placebo
Time frame: 24 weeks
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Novartis Investigative Site
Wichelen, Belgium, Belgium
Novartis Investigative Site
Buizingen, Belgium
Novartis Investigative Site
De Pinte, Belgium
Novartis Investigative Site
Genk, Belgium
Novartis Investigative Site
Mouscron, Belgium
Novartis Investigative Site
Nazareth, Belgium
Novartis Investigative Site
Oostham, Belgium
Novartis Investigative Site
Blagoevgrad, Bulgaria, Bulgaria
Novartis Investigative Site
Dimitrovgrad, Bulgaria, Bulgaria
Novartis Investigative Site
Plovdiv, Bulgaria, Bulgaria
...and 36 more locations