Onglyza approved for triple oral therapy

on the 2 April 2013

Onglyza (saxagliptin) can now be used in combination with metformin and a sulfonylurea in type II diabetes.

Following this licence extension for Onglyza (saxagliptin), all DPP4 inhibitors licensed in the UK are now suitable for use as triple oral therapy (in combination with metformin and a sulfonylurea).

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 (HbA_1c ≥7% and ≤10%).

Significant reductions in HbA_1c

Saxagliptin (n=127) significantly improved HbA_1c and post-prandial glucose levels compared with placebo (n=128). The HbA_1c 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.

View Onglyza drug record

Further information: BMS/AstraZeneca

Follow MIMS on Twitter