Materials and MethodsStudy Design and PatientsThis international, multicentre, double-blind, randomized, placebo-controlled and parallel group studyenrolled outpatients from Europe and Israel. Patientswere screened during routine visits to the diabetologist.Eligible patients were male or female outpatients, agedbetween 30 and 75, who had been diagnosed with type 2diabetes mellitus for at least 1 year and whose diabeteswas inadequately controlled by diet and metformintaken at a stable dose for at least 3 months. Patients wererequired to have HbA1c, >7.5 and