Onglyza™ US label update provides further evidence regarding use in renally impaired adults with type 2 diabetes

AstraZeneca and Bristol-Myers Squibb Company today announced that the US Food and Drug Administration (FDA) has approved the inclusion of data from two clinical studies in an update to the ONGLYZA (saxagliptin) US Prescribing Information for adult type 2 diabetes patients.

The renal study investigated the safety and efficacy of ONGLYZA in patients with moderate to severe renal impairment or end-stage renal disease (ESRD). The 12-week data showed that ONGLYZA 2.5 mg once daily significantly improved glycosylated hemoglobin (HbA1c) from baseline compared to placebo when added to patients’ current diabetes treatment. In patients with ESRD, ONGLYZA and placebo showed numerically comparable reductions in HbA1c. This finding is inconclusive because the trial was not adequately powered to show efficacy within specific subgroups of renal impairment. The incidence of adverse events was similar between ONGLYZA and placebo.

The data from a separate 52-week study comparing ONGLYZA to titrated glipizide in patients with inadequate glyceamic control on metformin therapy plus diet and exercise showed that ONGLYZA plus metformin provided similar HbA1c reductions from baseline. This conclusion may be limited to patients with baseline HbA1c comparable to those in the trial. ONGLYZA plus metformin also resulted in significantly less confirmed hypoglycaemia, as well as weight loss compared to weight gain versus titrated glipizide plus metformin.

ONGLYZA is indicated as an adjunct to diet and exercise to improve blood sugar (glyceamic) control in adults with type 2 diabetes mellitus in multiple clinical settings. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (dangerously high levels of ketones in the blood or urine).

If used with an insulin secretagogue such as a sulfonylurea, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycaemia. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.