Janssen's Invokana shows positive results in type 1 diabetes amid FDA safety warnings
Johnson & Johnson (NYSE: JNJ) subsidiary Janssen has announced results from a Phase II study showing glycemic improvements in patients with type 1 diabetes (T1DM) who were treated with its SGLT2 inhibitor Invokana (canagliflozin).
But in the same week as the trial results were announced the US Food and Drug Administration (FDA) upped its safety warnings on the drug.
The 18-week, randomized trial assessed the daily mean glucose, glycemioc variability and time spent in target glycemic ranges in 351 adults with inadequately controlled T1DM. Patients were administered canagliflozin 100mg, canagliflozin 300mg or placebo as an add-on to insulin.
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