Bristol-Myers Squibb Company and AstraZeneca
Study Finds That ONGLYZA saxagliptin When Added to Metformin was Non-Inferior to JANUVIA sitagliptin When Added to Metformin in Reducing Hemoglobin HbA1c in Adults With Type 2 Diabetes Mellitus
Published in Medical Letter on the CDC and FDA, October 25th, 2009
with inadequate glycemic control on metformin therapy alone found that the addition of treatment with ONGLYZA™ (saxagliptin) 5 mg per day achieved the primary objective of demonstrating non-inferiority compared to the addition of treatment with JANUVIA® (sitagliptin) 100 mg per day in reducing HbA1c from baseline. In this study, overall adverse events were reported at a similar rate for individuals taking ONGLYZA 5 mg plus metformin and JANUVIA 100 mg plus metformin. This study was submitted to the European Medicines Agency (EMEA) as part of the Marketing Authorization Application for...
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