Bristol-Myers Squibb Company and AstraZeneca today announced
that the FDA has approved the inclusion of data from two clinical studies in an
update to the ONGLYZA(TM) (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