This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Novartis Investigative Site
Bochum, Germany
Change from baseline in HbA1c
Time frame: 24 weeks
Change from baseline in fasting plasma glucose
Time frame: 24 weeks
Adverse event profiles including gastrointestinal tolerability and hypoglycemia
Time frame: 24 weeks
Responder rates
Time frame: 24 weeks
Change from baseline in insulin and proinsulin in a subgroup of patients
Time frame: 24 weeks
Change in systolic and diastolic blood pressure
Time frame: 24 weeks
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