OREANDA-NEWS. March 31, 2015. The positive opinion is based on the submission of robust clinical data from seven Phase III clinical trials that enrolled over 4,500 patients with T2D. These studies investigated the efficacy and safety data of empagliflozin plus metformin either alone or in combination with other blood glucose-lowering drugs (pioglitazone, sulfonylurea, DPP-4 inhibitors and insulin).

The results showed that treatment with empagliflozin (10mg and 25mg) when added to metformin, with or without other standard blood glucose-lowering drugs, led to statistically significant reductions in blood glucose, body weight and a clinically relevant reduction in blood pressure.

The most common side effect reported by patients in the clinical trials was hypoglycaemia (low blood glucose) in combination with insulin and/or sulphonylurea. In general, the adverse event profile of empagliflozin plus metformin HCl was in line with the known safety profile of the individual compounds empagliflozin and metformin.

The common side effects experienced with empagliflozin are urinary tract and genital yeast infections, increased urination and itching. The common side effects experienced with metformin are nausea, vomiting, diarrhoea, abdominal pain, loss of appetite and taste disturbance.