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To meet requirements of demonstrated cardiovascular (CV) safety for new diabetes drugs, the manufacturer of the sodium–glucose cotransporter-2 (SGLT2) inhibitor canagliflozin (Invokana) sponsored two nearly identical randomized trials that involved 10,000 patients with longstanding type 2 diabetes and either established CV disease or multiple CV risk factors. At baseline, patients' mean age was 63 and mean glycosylated hemoglobin (HbA1c) level was 8.2%, and most patients were using insulin, metformin, sulfonylurea, or drug combinations. Patients received canagliflozin or placebo.
During mean follow-up of 3.6 years, canagliflozin lowered HbA1c levels by an average of 0.6% compared with placebo, and the following clinical outcomes were noted:
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