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U.S. FDA expands indication for type 2 diabetes treatment Synjardy (empagliflozin/metformin hydrochloride) to include treatment-naïve adults

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Additional Relevant Details The SYNJARDY label was updated to include results from a phase III, double-blind, randomized, active-controlled study that evaluated the efficacy and safety of empagliflozin in combination with metformin as initial therapy compared with the individual components. In the study, at 24 weeks, the combination of empagliflozin 10 mg or 25 mg with metformin 1000 mg or 2000 mg resulted in significant reductions in A1C (a measure of average blood glucose over the past two to three months) compared with the corresponding dose of either component alone. SYNJARDY can cause serious side effects, including Lactic Acidosis (a buildup of lactic acid in the blood). Metformin, one of the medicines in SYNJARDY, can cause lactic acidosis, a rare, but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. SYNJARDY is not for the treatment of type 1 diabetes or diabetic ketoacidosis.
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Jul 19, 2016
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Related Keywords Synjardy, Type 2 Diabetes, Empagliflozin, Metformin Hydrochloride, Treatment-naive Adults, Lactic Acidosis, Buildup Of Lactic Acid In The Blood, Synjardy