The drug is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults with type 2 diabetes mellitus in multiple clinical settings.
“Many people with type 2 diabetes also experience kidney impairment, which can limit treatment options. With this update, Onglyza now includes efficacy and safety data in its label supporting its use in this important population,” said Elliott Sigal, MD, PhD, executive vice president, chief scientific officer and president, Research & Development, Bristol-Myers Squibb. “The study comparing Onglyza to titrated glipizide provides further evidence for the use of Onglyza as an add-on therapy to metformin.”
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 the Onglyza 2.5 mg once daily significantly improved glycoslated hemoglobin (HbA1c) from baseline compared to placebo when added to patients’ current diabetes treatment.
In patients with ESRD, the drug 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 glycemic 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 ; metformin also resulted in significantly less confirmed hypoglycemia, as well as weight loss compared to weight gain, versus titrated glipizide plus metformin.
