People with type 1 diabetes taking Invokana (canagliflozin) were more likely to experience diabetic ketoacidosis (DKA) than those taking placebo, a new trial finds.
Invokana is an SGLT2 inhibitor given to patients with type 2 diabetes, which helps to excrete glucose from the body via urine. The drug, which is relatively new, helps to lower blood glucose levels when used in conjunction with a healthy diet and regular physical activity.
In this new study, researchers at the University of Southern California examined how Invokana affected adults with type 1 diabetes as an add-on to insulin treatment.
All patients with type 1 diabetes had the condition for at least one year at baseline, and an HbA1c level of 7.0-9.0 per cent (53 mmol/mol – 74.9 mmol/mol). Their insulin regimens were all stable.
Patients with an HbA1c less than 8.0 per cent (63.9 mmol/mol) were recommended to reduce their basal insulin by 20 per cent; those with an HbA1c over 8.0 per cent were advised to reduce their basal rate by 10 per cent.
The patients assigned to Invokana treatment were compared to participants in a placebo group. None of the placebo group had any history of DKA.
Overall, there were three treatment groups. The first group received 100mg of canagliflozin once daily; the second group received 300mg canagliflozin; and the third took placebo.
After 18 weeks, the incidence of any ketone-related adverse events (AEs) was 5.1 per cent in the 100mg group and 9.4 per cent in the 300mg group. The incidence of serious AEs of DKA was 4.3 per cent with canagliflozin 100mg and 6.0 per cent with canagliflozin 300mg. In contrast, none of the placebo group suffered any ketone-related AEs.
Patients who experienced serious AEs had blood glucose levels ranging between 9.4-44.4 mmol/l. In the canagliflozin groups, urinary tract infection was a commonly experienced adverse effect.
The authors wrote: “Because of the potentially life-threatening nature of DKA in patients with type 1 diabetes, further development of SGLT2 inhibitor therapy as a treatment for type 1 diabetes should proceed with caution.”
The researchers also noted that future trials involving SGLT2 treatment in type 1 diabetes patients should involve regular monitoring of blood sugar and urine ketone levels, discontinuation of treatment if ketone levels remain too high and provide guidelines for patients on when to call a doctor.
The study was published in the online journal Diabetes Care.

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