To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
448
HbA1c reduction
Time frame: 24 weeks
HbA1c reduction in subpopulation treated with insulin and with metformin
Time frame: 24 weeks
HbA1c reduction in subpopulation treated with insulin and without metformin
Time frame: 24 weeks
Reduction in FPG (overall and subpopulations)
Time frame: 24 weeks
Responder rates (overall and subpopulations)
Time frame: 24 weeks
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)
Time frame: 24 weeks
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