Join the fight for approval of a life-altering therapy for people with Type 1 Diabetes (T1D) and support the approval of sotagliflozin as a new treatment for glycemic control to be used with insulin for the 1.7 million U.S. adults with T1D - a therapy already approved in Europe and urgently needed here at home. 

We, the undersigned, call upon the U.S. Food and Drug Administration (FDA) and FDA Commissioner Makary to prioritize the approval of sotagliflozin - a treatment that was approved in Europe on the same data 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 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 1920’s, 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 21% achieve an A1C less than 7%), facing risks of both hyperglycemia and hypoglycemia, which increase the risk for long-term complications. 

Achieving optimal A1C levels with insulin alone is challenging due to the limitations of subcutaneous insulin replacement. Many patients experience excessive weight gain and peripheral insulin resistance, both of which are risk factors for hypertension and cardiovascular disease. 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 distress.

Why Sotagliflozin Matters:

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 (CKD).

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. (#MAHA)

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 (DKA). (#T1DTreatmentNow)

Call to Action:

We respectfully urge the FDA to prioritize the approval of sotagliflozin. Every day without this potentially life-changing treatment is a day that people with T1D must continue to endure an exhausting regimen with limited options and with poor outcomes. By achieving glycemic control, we can stabilize kidney function, mitigate long-term disease progression, and reduce the significant morbidity and mortality that the cardiorenal burden puts on patients with T1D and CKD. We trust in the FDA’s commitment to patient safety and thorough review, and we believe that the benefits of sotagliflozin merit prompt consideration and approval.

Thank you for your support!

Steven Edelman, MD

Founder and Director

Taking Control Of Your Diabetes (TCOYD.com)