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Join the efforts to bring a life-changing Type 1 Diabetes medication to those who need it most

Sotagliflozin, a new treatment for glycemic control for Type 1 Diabetes, has already been approved in Europe and is urgently needed here at home. 

We urgently call upon the Food and Drug Administration (FDA) to prioritize the approval of sotagliflozin — a treatment that was approved in Europe five years ago. Sotagliflozin offers the opportunity to achieve better glycemic control, stabilize kidney function and reduce the rates of morbidity and mortality associated with Type 1 Diabetes (T1D). Patients and their healthcare teams deserve the right to evaluate the risk-benefit ratio and choose the best course of treatment — one that could dramatically change the trajectory of this disease.

This petition represents the voices of T1D patients, families, healthcare providers and advocates who are eager for innovative and effective options to manage this life-altering condition.

Background on T1D

The FDA has approved many oral agents for Type 2 Diabetes but has never approved any for T1D patients, who, since life-saving insulin was discovered in the 1920s, have had to rely only on a strict regimen of insulin therapy, lifestyle management and constant monitoring. Despite advances in treatment and motivation to live well with diabetes, the majority of patients struggle to maintain adequate blood glucose levels (only 23 percent achieve an A1C of less than 7 percent1), facing risks of both hyperglycemia and hypoglycemia, as well as the risk for long-term complications.

The burden to achieve adequate control using current treatment options on individuals and families, along with the physical and psychological impacts, can be overwhelming and lead to diabetes burnout.

Why sotaglifozin matters

  1. Improved quality of life: Sotagliflozin offers potential benefits that can significantly ease the daily burden of managing T1D, including better glucose control and reduced risk of hypoglycemia and chronic kidney disease.
  2. Reduction of long-term complications: Early and effective treatments like sotagliflozin could potentially reduce the risk of complications affecting eyes, kidneys, heart and nerves, benefiting both patients and the healthcare system.
  3. Broad support from the T1D community: The T1D community – comprising patients and their health care teams – balances risks and benefits every day, and their support for sotagliflozin reflects the community’s need for more advanced and effective therapies, as well as its ability to manage the risks associated with sotagliflozin, including diabetic ketoacidosis.

Show your support for people with T1D by signing on to the petition.

Sources

1Factors Associated With Improved A1C Among Adults With Type 1 Diabetes in the United States, National Library of Medicine, Accessed June 2025


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