Assessments

As detailed previously,20 the primary objective of the VIRTUE study was to assess the proportion of Muslim patients with one or more HEs during the fasting period receiving vildagliptin or SU alone (where approved) or combined with metformin. HEs were further defined as either grade 1 (mild), ie, any reported symptoms by the patient and/or any blood glucose measurement <3.9 mmol/L (70 mg/dL), or grade 2 (severe), defined as requirement of third-party assistance. Secondary objectives included changes in HbA1c and body weight from prefasting baseline and overall safety, as assessed by monitoring of adverse events (AEs).