Efficacy and Safety of Dapagliflozin (Forxiga) in Type 2 Diabetics Treated with High Doses of Insulin

This trial assessed the efficacy and safety of a new diabetes drug, Dapagliflozin (Forxiga). Results revealed that the drug helps control difficult cases of type 2 diabetes with only moderate side-effects.

Dapagliflozin is a drug recently approved by the European Medicines Agency for the treatment of diabetes. Its mechanism of action differs from traditional diabetes drugs: it helps excrete excess blood sugar in the urine. Currently, clinical trials are underway to confirm the drug’s efficacy in order to gain FDA approval. Some type 2 diabetes patients have difficulty controlling blood sugar levels. These patients usually need high doses of insulin which can cause weight gain and water retention in the body. Diabetes control is usually assessed by measuring the HbA1c level (the glycated hemoglobin).

The present study enrolled 808 patients with poorly controlled type 2 diabetes, requiring at least 30 units of insulin per day. Some received up to two other diabetes drugs. Patients were assigned to 4 groups, 3 of the groups received Dapagliflozin in doses of 2.5 mg, 5 mg and 10 mg respectively. The remaining group received placebo (an inactive drug). Treatment was given for 24 weeks.

Compared to placebo, patients receiving Dapagliflozin had significantly better blood sugar control, needed lower doses of insulin and lost weight. Genital and urinary tract infections were however more frequent in the Dapagliflozin groups (more with higher doses). There was no significant difference in the frequency of major episodes of hypoglycemia (extremely low blood sugar). Minor episodes of hypoglycemia were however more common in patients treated with Dapagliflozin.

Dapagliflozin is a viable option to reduce insulin doses and to improve blood sugar control in patients with hard-to-manage type 2 diabetes. Side effects were manageable, but long-term research is needed to confirm the safety of this new drug (patients were followed up for only 48 weeks in this study).

The study was funded by AstraZeneca and Bristol-Myers Squibb, the manufacturers of Dapagliflozin. As of January 2014, dapagliflozin is approved by the FDA  for the management of type 2 diabetes.