This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
798
To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF).
Time frame: 52 weeks
To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure.
Time frame: 52 weeks
To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment.
Time frame: 52 weeks
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Benešov, Czech Republic, Czechia
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Havířov, Czech Republic, Czechia
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Litomyšl, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Prague, CZE, Czechia
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Broumov, Czechia
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Pardubice, Czechia
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Copenhagen NV, Denmark
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Copenhagen S, Denmark
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Frederiksberg, Denmark
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