The labeling for Onglyza (saxagliptin; Bristol-Myers Squibb) has been updated to include data from two clinical trials: a study of Onglyza in patients with moderate to severe renal impairment or end-stage renal disease (ESRD) and a second comparator study of Onglyza + metformin versus glipizide + metformin. The 12-week data from a randomized, double-blind, placebo-controlled trial in 170 adult patients with type 2 diabetes with moderate to severe renal impairment or ESRD showed that Onglyza 2.5mg once daily significantly improved HbA1c from baseline by -0.9% compared to -0.4% for placebo (mean baseline HbA1c 8.1%; p<0.01).
Data from a separate 52-week, randomized, double-blind, active-controlled study of 858 adult patients with type 2 diabetes and inadequate glycemic control comparing Onglyza + metformin to glipizide + metformin showed that Onglyza + 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 + metformin.
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