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Join Trial Studying New Treatment for Type 1 Diabetes and Chronic Kidney Disease

3 Minute Read
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A trial is recruiting adults with type 1 diabetes and chronic kidney disease to investigate the drug sotagliflozin for protecting kidney function. Despite concerns about diabetic ketoacidosis (DKA), previous research suggests that a DKA prevention plan can minimize risks.

Trial status: Recruiting

Clinical Trials Identifier: NCT06217302

Trial Name: Sotagliflozin to Slow Kidney Function Decline in Persons with Type 1 Diabetes and Diabetic Kidney Disease (SUGARNSALT)

Diabetes Type: Adults with type 1 diabetes and diabetic kidney disease

Trial Sponsor: Joslin Diabetes Center

Why is this study important?

Sotagliflozin is an SGLT-2 inhibitor approved to treat type 2 diabetes, heart failure, and chronic kidney disease. Specifically, the medication has been shown to prevent or delay end-stage kidney disease in people with type 2 diabetes. However, it's unclear if these drugs work the same way and are safe for people with type 1 diabetes. Studies that have been done on SGLT-2 medications in people with type 1 diabetes have shown an increased risk of diabetic ketoacidosis (DKA), a serious complication. 

However, one study showed that although still elevated compared to placebo, a DKA prevention plan could help reduce this risk. The current trial will test whether a similar prevention plan can help improve kidney health in people with type 1 diabetes and moderate to advanced chronic kidney disease over three years. If successful, the trial will provide data that might be used to seek FDA and Health Canada approval of sotagliflozin for people with type 1 diabetes and kidney disease.

How does the trial work?

Participants will be randomly assigned to either the active treatment or placebo group. Those assigned to the treatment group will receive sotagliflozin (one 200 mg tablet per day) for three years, followed by two months without the medication (the “wash-out” period).

To determine the safety and effectiveness of sotagliflozin, researchers will measure participants’ eGFR (a measure of kidney function) after the wash-out period. The DKA risk mitigation plan will include enhanced participant education, close follow-up with study staff, continuous glucose monitoring, and blood ketone testing 

Are you interested in participating?

You may be eligible to participate if you are 18-75 years of age and have:

  • Type 1 diabetes, continuously treated with insulin within one year from diagnosis
  • Have had type 1 diabetes for eight years or longer
  • eGFR between 20 and 60 and urine ACR of 200 or higher
  • An A1C of less than 10% 

People with type 2 diabetes are not eligible for this study. This trial is currently recruiting in two locations (Boston, MA and Syracuse, NY), with 16 more sites anticipated to begin recruiting soon throughout the U.S. and Canada. See a full list of inclusion/exclusion criteria here.

Learn more about type 1 diabetes and diabetic kidney disease here: