Synjardy approved for type 2 diabetes treatment in the European Union

Synjardy, a new single-pill combination therapy, has been approved by the European Commission to treat adults with type 2 diabetes.
Syndardy is intended to improve blood glucose control alongside diet and exercise. It combines a sodium glucose cotransporter 2 (SGLT2), metformin hydrochloride (HCI) and empagliflozi, which was approved in the European Union in May 2014.
The drug is made by Eli Lilly and Company and Boehringer Ingelheim for type 2 patients whose blood sugar levels are either inadequately controlled by the maximum dose of metformin alone, or metformin alongside other glucose-lowering products.
Patients who are being treated with empagliflozin and metformin as separate tablets will also be eligible for Synjardy treatment.
Clinical trials
Results from Phase III clinical trials of empagliflozin as an add-on to metformin led to clinically relevant reductions in blood glucose, weight and blood pressure.
These results were still observed after other blood glucose-lowering drugs were added, while side effects included urinal tract infections from empagliflozin and nausea from metformin. This was consistent with the safety profiles of the respective drugs.
Synjardy, which is to be taken twice-daily, will be made available in the UK as two different doses: 5mg empagliflozin with 850mg/1000mg metformin HCI or 12.5mg empagliflozin with 850mg/1000g metformin HCI.
Synjardy should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.