PRINCETON, N.J., and WILMINGTON, Del. — The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug's prescribing information.
Bristol-Myers Squibb and AstraZeneca said the Food and Drug Administration approved the labeling update for Onglyza (saxagliptin), which now includes efficacy and safety information about the drug's effects on patients with renal impairment or end-stage renal disease.
One study was a 12-week trial involving patients with severe kidney damage or end-stage kidney disease, which compared Onglyza with the patients' current treatment plus a placebo. The results showed patients experienced greater improvements to their blood sugar levels, those the rates of side effects were the same.
In the second study, which was a 52-week trial, compared Onglyza with titrated glipizide in patients with inadequate glycemic control on metformin therapy and were dieting and exercising. The study showed that Onglyza plus metformin provided similar HbA1c reductions.
“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, EVP, chief scientific officer and president, research and development at 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 drug makers added that renal function should be tested prior to taking Onglyza and periodically thereafter.