Is dapagliflozin add-on therapy beneficial?

This trial evaluated the efficacy of dapagliflozin (Forxiga) in patients with type 2 diabetes mellitus (T2DM) uncontrolled with sitagliptin (Januvia), with or without metformin (Glucophage). 

T2DM is a condition in which the cells of the body are failing to use insulin properly (insulin resistance), resulting in high blood sugar levels. Therefore, T2DM patients need intensive therapy to regulate their blood sugar levels. T2DM therapy is based on diet, exercise and different blood sugar lowering medications, alone or in combinations. However, some of these medications have side effects such as hypoglycemia (abnormally low blood sugar levels), and weight gain. Therefore, efficiency of drugs should be measured by weight control and a value of the glycated hemoglobin or HbA1c under 7% (a test that measures an average of blood sugar levels from the past 2 to 3 months). In this trial, combination therapy with dapagliflozin was tested. Dapagliflozin has a unique mechanism that allows it to be active independently to insulin secretion, by increasing glucose loss through urination. Therefore, dapagliflozin may be appropriate in treating a wide range of T2DM patients.  

451 patients with uncontrolled T2DM were chosen for the trial. The participants were randomly assigned to receive either dapagliflozin 10 mg or a placebo (a substance with no medical effect used as a control when testing new drugs) to current treatment with sitagliptin 100 mg with or without metformin. The efficacy of the treatment was measured through the value of the HbA1c and weight control.

After 24 weeks of treatment, 27.8% of the patients treated with dapagliflozin achieved a value of HbA1c under 7%, compared with 17.9% of patients in the control group. In addition, dapagliflozin patients showed lower body weight versus the placebo group. After 48 weeks of follow-up, 31.8% of patients in the dapagliflozin group discontinued the therapy due to lack of efficiency compared with 57.6% in the control group. Regarding adverse effects, 9% of participants in the dapagliflozin group reported genital infections, compared to 0.4% in the control group. 

This trial showed that patients with uncontrolled T2DM patients can benefit from dapagliflozin add-on therapy. However, there is a slight tendency to develop genital infections when using dapagliflozin.

As of January 2014, dapagliflozin is approved by the FDA  for the management of type 2 diabetes.

Consult with your physician about the best combination therapy for your situation.