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FDA weighs risks of new treatment for type 1 diabetes

Decision expected on approval of use of SGLT1/SGLT2 inhibitors in combination with insulin therapy.

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Achieving Hba1c targets for people with type 1 diabetes (T1D) can be challenging due to the sole reliance on injectable insulins, but a new day may be dawning.  While the FDA weighs the risks of a new oral treatment for adults with type 1 diabetes in combination with insulin therapy, the type 1 diabetes community continues to advocate for a positive outcome.  In question is the safety of the drug and questions remain. Approval is split down the middle.

In January 2019, the FDA advisory panel voted ‘eight to eight’ on the overall benefits of the drug in question.  The SGLT2/SGLT2 inhibitor Zynquista™ (sotagliflozin), outweighed the risks to support approval. Developed by Lexicon Pharmaceuticals and France’s Sanofi, the FDA will consider the advisory panel’s vote when they make a final decision on March 22, 2019.

What are SGLT1/SGLT2 inhibitors?

Sodium glucose cotransporter 2 (SGLT2) inhibitors are a class of oral medications that help people with type 2 diabetes achieve improved  targets and weight loss.  SGLT2 works by blocking the reabsorption of glucose by the kidneys.  They increase glucose in the urine and lower blood glucose levels.  SGLT2 inhibitors are not approved for use by people with type 1 diabetes.

The sodium-glucose cotransporter type 1 (SGLT1) is the primary transporter for absorption of glucose in the digestive tract.  SGLT1 delays postprandial glucose excursion or high blood glucose after a meal.

The drug under investigation is a dual SGLT1/SGLT2 inhibitor which could help decrease blood glucose excursions after eating, not often achievable with insulin alone.  In the most recent study, patients who received sotagliflozin in addition to insulin had sustained reduction in HbA1c levels and body weight.  Participants experienced a reduction of hypoglycaemia and lower total daily insulin dose compared to insulin alone.

What are the risks?

Investigators in the latest study noted that 20 (7.6%) of treated patients on sotagliflozin had experienced Diabetes Ketoacidosis (DKA).  The FDA Committee noted a “consistent and clinically meaningful increase” adding “while all patients with type 1 diabetes may to some degree be at risk for DKA, sotagliflozin therapy clearly increases that risk, and the risk may be unpredictable.”

Many healthcare providers caring for people with diabetes are in agreement that with careful monitoring and education, approval could be a huge gain. Carolyn Robertson, a certified diabetes educator (CDE) with over 35 years of experience in diabetes education explains how, “This class of drugs are an appropriate adjunctive treatment in T1D – they lower blood sugar levels, reduce glycemic excursions and increase time in range. However, they have risks and require appropriate patient selection as well as initial and repeated patient education to assure their safe use.”

The FDA’s decision will likely have an impact on the 1.3 million people who live with T1D in the US and the estimated 40,000 people who are diagnosed each year. (American Diabetes Association). The dual therapy SGLT1/SGLT2 inhibitor could be the first approved oral therapy for people with type 1 diabetes in combination with insulin to improve glucose management. With so little innovation in the category, this could be the first meaningful step in improving outcomes. Stay tuned.

Elizabeth Snouffer is Editor of Diabetes Voice. Connect with her on Twitter @ElizabethType1


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