Diabetes Combo Gets FDA Approval

The FDA has approved a fixed-dose combination of canagliflozin and metformin hydrochloride extended release (Invokamet XR/Janssen) treatment for diabetes.

The combination is meant for first-line use, as an adjunct to diet and exercise, to improve blood glucose control in adults with type 2 diabetes. The product combines canagliflozin with an extended release formulation of metformin.

The drug combination is mean for adults when they are first diagnosed with diabetes, or as additional therapy for patients whose A1C levels are not well controlled with either agent alone.

Phase 3 studies showed the combination worked better than metformin alone, sitagliptin plus meformin, or glimepiride plus metformin. It also showed patients had greater reductions in body weight and systolic blood pressure.

Potential side effects included genital yeast infections, urinary tract infections, and lactic acidosis. The drug combination may also increase the risk of bone fracture in some patients, and long-term use could cause a decrease in vitamin B12.