Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the ONGLYZA™ (saxagliptin) U.S. 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 glycoslated 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 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 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. 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).

"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, M.D., Ph.D., 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."

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 hypoglycemia. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.

Efficacy and safety of ONGLYZA in type 2 diabetes patients with renal impairment

A total of 170 adult patients participated in a 12-week, randomized, double-blind, placebo-controlled trial. The study was conducted to evaluate the efficacy and safety of ONGLYZA 2.5 mg once daily compared with placebo in patients with type 2 diabetes and moderate (n=90) or severe (n=41) renal impairment or ESRD (n=39). In this trial, 98% of patients were using background anti-diabetic medications (75% were using insulin and 31% were using oral anti-diabetic medications, mostly sulfonylureas).

After 12 weeks of treatment, ONGLYZA 2.5 mg once daily provided significant improvement in HbA1c compared to placebo. The ONGLYZA 2.5 mg group (mean baseline HbA1c 8.4%) demonstrated a greater adjusted mean change in HbA1c from baseline of -0.9% compared to -0.4% for placebo (mean baseline HbA1c 8.1%; p50 mL/min). Assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter.

Efficacy and safety of ONGLYZA plus metformin vs. titrated glipizide plus metformin in type 2 diabetes patients

In a 52-week, randomized, double-blind, active-controlled study of 858 adult patients with type 2 diabetes and inadequate glycemic control, ONGLYZA (n=428; mean baseline HbA1c 7.7%) and titrated glipizide (n=430; mean baseline HbA1c 7.6%) resulted in similar mean reductions from baseline in HbA1c when added to metformin therapy. This conclusion may be limited to patients with baseline HbA1c comparable to those in the trial (91% of patients had baseline HbA1c of

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