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INVOKANA® monotherapy demonstrated significantly greater reductions in fasting plasma glucose (FPG) vs placebo at 26 weeks1-3
Secondary Endpoint: Adjusted Mean Change in FPG From Baseline at 26 Weeks (mg/dL)
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Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema and anaphylaxis, were reported with INVOKANA®; these reactions generally occurred within hours to days after initiation. If reactions occur, discontinue INVOKANA®, treat per standard of care, and monitor until signs and symptoms resolve.
The efficacy and safety of INVOKANA® monotherapy were assessed in subjects with type 2 diabetes mellitus who were inadequately controlled with diet and exercise. In this 26-week, double-blind, placebo-controlled study, 584 patients were randomized to receive placebo (n=192), INVOKANA® 100 mg (n=195), or INVOKANA® 300 mg (n=197). Mean baseline A1C values were, respectively, 7.97%, 8.06%, and 8.01%. The primary endpoint was the change in A1C from baseline to week 26. Prespecified secondary endpoints included change in fasting plasma glucose, change in percent body weight, and change in systolic blood pressure.1,2
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