COMMENTARY

Spotlight on SGLT Inhibitors for Type 1 Diabetes: EASD 2019

Thomas Danne, MD

Disclosures

September 25, 2019

This transcript has been edited for clarity.

Hello. I'm reporting from the European Association for the Study of Diabetes Congress in Barcelona.

We heard some news about the treatment of type 1 diabetes with SGLT inhibitors. We know these drugs from the treatment of type 2 diabetes, but lately they have been discussed as a potential adjunct therapy to insulin for patients with type 1 diabetes.

Studies have shown a multitude of positive effects. Due to the increased glucose loss attributed to this drug, we see a reduction HbA1c that is pretty steady through three study programs: InTandem for sotagliflozin, DEPICT for dapagliflozin, and EASE for empagliflozin. Most patients in these trials had reduced glycemic variability and fewer blood glucose swings, which are troubling for many with type 1 diabetes. That adds up to nearly 3 hours more in range, between 70 and 180 mg/dL.

The SGLT2 inhibitor's mechanism of action does not increase the risk for hypoglycemia. It's a new approach where we're able to lower the HbA1c—not at the expense of increasing the risk for hypoglycemia—and reduce glycemic variability. People also lose approximately 3 kg of weight when they take this drug as adjunct therapy, and for those with elevated blood pressure, studies show an improvement in blood pressure.

We have not yet proven that this drug improves cardiorenal outcomes in type 1 diabetes because these are short-term studies. But when I look at the results in type 2 diabetes, or even results from the recent European Society of Cardiology Congress in patients without diabetes, where it also showed an improvement of cardiovascular outcomes, I find it difficult to believe that, in the long run, it won't also prove to be beneficial for cardiovascular outcomes in type 1 diabetes. This is clearly a needed intervention for our patients with type 1 diabetes because their cardiovascular mortality is still quite elevated.

Risk Mitigation

SGLT inhibitors have many advantages, but one focus during this meeting was potential disadvantages. If we look at the labeling from the European Medicines Agency, it was only approved for patients with type 1 diabetes older than 18 years with a body mass index > 27. This is because of an increased risk for diabetic ketoacidosis due to a shift toward more ketone production.

During the meeting, we discussed many possible options for risk mitigation. We introduced a patient education program that will be evaluated, a program for nurses and other healthcare professionals, and informational material for emergency physicians. And, of course, things like patient alert cards to mitigate this diabetic ketoacidosis risk.

Time will tell whether these risk mitigation efforts will be successful. An international consensus that was just published in the June issue of Diabetes Care[1] recommended that these be put in print and into different materials. I'm confident that at some time this drug will be reevaluated for regulatory approval in the United States. Of course, we will see in Europe whether there is a positive risk-benefit ratio.

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