New Glycemic Control Combo Approved for Type 2 Diabetes

The US Food and Drug Administration approved a new glycemic control treatment for type 2 diabetes in adults, a combination product made of empagliflozin (Jardiance/ Boehringer Ingelheim) and metformin hydrochloride. It will be marketed as Synjardy in a joint venture with Eli Lilly.

The new treatment is the third product containing empagliflozin to get FDA approval. The others are Jardiance and empagliflozin/linagliptin (Glyxambi/Boehringer Ingelheim)

Synjardy is a tablet. It carries a boxed warning noting it can cause lactic acidosis.

Clinical trials leading to the approval were conducted by giving empagliflozin and metformin to subjects with type 2 diabetes either in combination with sulfonylurea or alone.

The drug combo was approved in Europe in May 2015.

It is meant to be used in combination with diet and exercise to improve blood sugar levels in people with type 2 diabetes who either are already taking both medications contained in Synjardy or whose glucose is not sufficiently controlled with only one of those medications.

Patients with type 1 diabetes or who have diabetic ketoacidosis should not take Synjardy. Patients with severe kidney problems, including those on dialysis, should not take the drug.

Among the potential side effects are dehydration, hypoglycemia, genital yeast infections, urinary tract infections, vitamin B12 deficiency, and increased cholesterol levels.