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At T1D Exchange, we encourage people with type 1 diabetes (T1D) to use their voices to help inform policies and care for the T1D community.
Now, the U.S. Food and Drug Administration (FDA) wants to hear your thoughts on an SGLT inhibitor drug developed by Lexicon Pharmaceuticals called sotagliflozin for use by people with T1D.
Sotagliflozin is a pill taken once daily in addition to one’s standard insulin regimen. According to the Lexicon website, when given to adults with T1D as an oral adjunct to insulin, the drug resulted in consistent and significant reductions in HbA1c, body weight, and systolic blood pressure, and significant improvements in time in target blood sugar range and patient-reported outcomes. Consistent with selective SGLT2 inhibitors, clinical trials with sotagliflozin also showed an increased risk of diabetic ketoacidosis (DKA), but several leaders in the diabetes community consider these risks manageable with appropriate patient selection, education, and ketone monitoring.
Although sotagliflozin was approved in Europe for use by some adults with T1D, the FDA decided not to approve it in the U.S. in March 2019. Now, the FDA is reconsidering approving sotagliflozin and is soliciting comments from the public on this important matter.
Between now and May 3rd, you can submit comments directly to the FDA to tell them about your views on whether sotagliflozin should be approved for use by people with T1D in the U.S. To send your feedback directly to the FDA, click the blue “Comment” button near the top of the page at the website below.
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