The oral hypoglycaemic has been licensed for triple oral therapy, in combination with metformin and a sulfonylurea, in patients with type II diabetes inadequately controlled by dual therapy plus diet and exercise.
Investigators enrolled 257 patients with type II diabetes in a randomised, double-blind, placebo-controlled 24-week study to evaluate the efficacy and safety of saxagliptin (5mg once daily) in combination with metformin plus a sulfonylurea in patients with inadequate glycaemic control (HbA1c ≥7% and ≤10%).
Significant reductions in HbA1c
Saxagliptin (n=127) significantly improved HbA1c and post-prandial glucose levels compared with placebo (n=128). The HbA1c change for saxagliptin compared with placebo was -0.7% at week 24.
The safety profile of saxagliptin when used in triple oral therapy was similar to that observed in patients taking saxagliptin as dual oral therapy, but with an increased incidence of dizziness, fatigue and flatulence.
Further information: BMS/AstraZeneca