Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

Launched by NOVARTIS PHARMACEUTICALS · Apr 19, 2012

Keywords

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Gender

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Eligibility criteria

• • Inclusion criteria
• • 1. Outpatients who were 20 years of age and older with diagnosis of T2DM.
• • 2. Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
• • 3. Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
• • 4. Understood the nature of the study, and had signed informed consent form.
• • Exclusion criteria
• • 1. Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
• • 2. Patients with renal dysfunction defined as creatinine clearance \< 60 ml/min at Visit 1.
• • 3. Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT \> 3 ULN at Visit 1.
• • 4. Female patients who needed to lactate during the study.