Product News and Recalls

First Study on SGLT2 Inhibitor Use in Type 1 Diabetics Shows Increased Diabetic Ketoacidosis

sglt2 inhibitor results fall shortAccording to a Medscape article, the results of the first-ever Phase 2 study of sodium-glucose cotransporter-2 (SGLT2) inhibitor use in type 1 diabetes patients have been reported—and they may not be as reassuring as many had hoped. The data were presented at the European Association for the Study of Diabetes (EASD) 2015 Meeting by Robert R. Henry, MD, chief of the Division of Endocrinology and Metabolism at the University of San Diego, California’s VA Center for Metabolic Research. According to the study, increased rates of serious diabetic ketoacidosis, hypoglycemia, and infection were observed in patients taking 100-mg and 300-mg doses of canagliflozin (Invokana).

SGLT2 inhibitors’ connection to diabetic ketoacidosis was first brought to the public’s attention in a May safety communication from the U.S. Food and Drug Administration (FDA). In it, the agency warned that diabetic ketoacidosis, a life-threatening blood condition, had been reported in some patients treated with the new class of diabetes medication. Although SGLT2 inhibitors are not approved for use in type 1 diabetes patients, a large number of the FDA’s diabetic ketoacidosis cases originated in this user base.

Henry says that the ketoacidosis cases reported in the study all occurred in the presence of precipitating factors. “Implementation of additional mitigation strategies in future studies may substantially reduce DKA in patients with type 1 diabetes treated with canagliflozin.” He admits, however, that the researchers had suspected ketoacidosis might be an issue during the study, and had included an investigation of “ketone-related adverse effects” in their design.

Whatever the confounding factors, medical experts will be interested by the study’s results. According to Medscape, “Ketone-related adverse events were seen in 5% of those on 100 mg and 9% of those taking 300-mg canagliflozin, vs none with placebo.” Patients in the 100-mg and 300-mg groups also showed higher rates of hypoglycema and urinary tract infections.

Talk to your doctor about any health concerns you may have. If you or a loved one was diagnosed with diabetic ketoacidosis after using an SGLT2 inhibitor like Invokana, contact Lopez McHugh today to speak free of charge with a qualified pharmaceutical attorney.