Results from a 24-week Phase III study have demonstrated that saxagliptin, when used in combination with metformin as an initial therapy, produced reductions across all key measures of glucose control studied (glycosylated hemoglobin level (A1C), fasting plasma glucose and postprandial glucose in treatment-naive people with inadequately controlled type 2 diabetes, compared with monotherapy with saxagliptin or metformin.
The initial combination of saxagliptin and metformin was well tolerated during the course of the study, and more people were able to achieve target A1C of less than 7%, compared with monotherapy with saxagliptin or metformin.
The study was designed to assess saxagliptin as an initial combination therapy with metformin versus each agent alone. The data represent findings from a 24-week, randomized, double-blind, active-controlled study of 1,306 people with type 2 diabetes (ages 18-77) who were treatment naive and whose A1C level was greater than or equal to 8% and less than or equal to 12%.
The primary endpoint of the study was the change from baseline to week 24 in A1C. The secondary endpoints included the proportion of individuals achieving the American Diabetes Association recommended A1C target of less than 7%, the proportion of individuals achieving the International Diabetes Federation recommended A1C target of less than or equal to 6.5% and changes from baseline in FPG and PPG (a measure of a person’s blood glucose after a meal), measured during an oral glucose tolerance test.