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AstraZeneca, BMS say late-stage trial of Onglyza met primary endpoint

SAN DIEGO — A cobranded Type 2 diabetes treatment may help reduce blood-sugar levels among patients when combined with insulin (with or without metformin), according to a late-stage clinical trial.

AstraZeneca and Bristol-Myers Squibb said that when Onglyza (saxagliptin) in the 5-mg strength was combined with insulin (with or without metformin), patients saw significantly lower HbA1C levels by an average of about 0.73% by the end of the phase-3 trial, compared with a placebo-insulin (with or without metformin) combination.

Conducted over a period of 24 weeks, the multicenter, randomized, placebo-controlled, double-blind study included 455 Type 2 diabetes patients between the ages of 18 years and 78 years. All of the patients enrolled in the study were diagnosed as having inadequate glycemic control, AstraZeneca and BMS said.

The data was presented at the American Diabetes Association's 71st annual Scientific Sessions in San Diego.

“Type 2 diabetes is a chronic, progressive disease, and many patients who require insulin may need to increase their dosage over time to help control their blood-sugar levels,” said Bernard Charbonnel, professor of endocrinology and metabolic diseases at the University of Nantes, France, and principal investigator of the study. “The study showed that Onglyza 5 mg used with insulin helped improve HbA1C in these adult patients with Type 2 diabetes.”

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