The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
317
1000 bid metformin
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
Time frame: 24 weeks
FPG reduction
Time frame: 24 weeks
Safety and tolerability
Time frame: 24 weeks
Body weight change from baseline
Time frame: 24 weeks
Changes in the fasting lipid profile
Time frame: 24 weeks
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Pine Bluff, Arkansas, United States
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Long Beach, California, United States
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Denver, Colorado, United States
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Bangor, Maine, United States
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Billings, Montana, United States
Novartis Investigative Site
New Brunswick, New Jersey, United States
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Trenton, New Jersey, United States
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Wilmington, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Uniontown, Pennsylvania, United States
...and 53 more locations