Tuesday morning, Bristol-Myers Squibb Co. (BMY) and AstraZeneca (AZN) announced that their diabetes drug saxagliptin has met its study goal in a late-stage trial.
The company said that saxagliptin, when used in combination with metformin as an initial therapy, produced significant reductions across all key measures of glucose control studied in treatment naïve people with inadequately controlled type 2 diabetes, compared to monotherapy with saxagliptin or metformin.
The initial combination of saxagliptin and metformin was well tolerated over the course of the study, and significantly more people were able to achieve target A1C of less than 7%, compared to monotherapy with saxagliptin or metformin.
The 24-week phase III study, which involved 1,306 people with type 2 diabetes, compared the combination's effectiveness with either saxagliptin or metformin alone.
The primary endpoint of the study was the change from baseline to Week 24 in A1C. The secondary endpoints included the proportion of individuals achieving the A1C target of less than 7%, the proportion of individuals achieving the A1C target of less than or equal to 6.5% and changes from baseline in FPG and PPG, measured during an oral glucose tolerance test.
The drug candidate saxagliptin is already under review with the FDA and the European Medicines Agency. The companies have proposed the name Onglyza which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.
BMY is currently trading at $22.42, up 10 cents. AZN is currently trading at $46.42, up 46 cents or 1.00%.
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