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news.Bristol-Myers Squibb Company and AstraZeneca have announced that the US Food and Drug Administration 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.
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The renal study evaluated the safety and efficacy of Onglyza in patients with moderate to severe renal impairment or end-stage renal disease (ESRD).
The 12-week data revealed that Onglyza 2.5mg once daily significantly improved glycoslated haemoglobin (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.
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 revealed that Onglyza plus metformin provided similar HbA1c reductions from baseline.
Onglyza plus metformin also resulted in significantly less confirmed hypoglycemia, 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 (glycemic) control in adults with type 2 diabetes mellitus in multiple clinical settings.
Bristol-Myers Squibb executive vice president, chief scientific officer and president of R&D, Elliott Sigal said that 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," Sigal said.