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Sugar N Salt

Effectiveness and safety of sotagliflozin (SOTA) in slowing kidney function decline in persons with type 1 diabetes and moderate to severe diabetic kidney disease: The
SUGARNSALT Trial

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Study Description

IRB #

STUDY00000249

NCT #

NCT06217302

Principal Investigator

Petter Bjornstad MD

Study Location

UW Medicine Diabetes Institute

This study is a multi-center, international, double-masked, placebo-controlled, parallel- group randomized clinical trial with T1D and moderate to advanced diabetic kidney disease. After a run-in period of 6 weeks, during which diabetes care will be standardized and education on monitoring and minimizing DKA completed, eligible study participants will be randomized in a 1:1 ratio to receive placebo or once daily 200 mg SOTA.

Purpose

Diabetic kidney disease (DKD) is the leading cause of kidney failure in the USA and developed world. Also, DKD is associated with a markedly higher risk of cardiovascular disease (CVD). The purpose of this study is to find out if a drug called Sotagliflozin (SOTA) can slow kidney function decline in persons with type 1 diabetes and moderate to severe DKD.

What You Will Do

If you join the study, you will:

  • provide blood and urine samples
  • wear a Continuous Glucose Monitoring (CGM) and provide CGM data to the study staff
  • check your blood levels of beta-hydroxybutyrate (BHB or ketone body), and provide BHB data to the study staff.

Duration

  • Treatment will be continued for 3 years and will be followed by an 8-week washout period.

Learn More

FAQ Title

Learn more about  how you can contribute to important research by volunteering for Sugar N Salt.

Who Can Participate?

Inclusion Criteria:

  •  are between the ages of 18 to 75
  •  are diagnosed with T1D ≥ 8 years and continuously treated with insulin startedwithin one year from diagnosis
  • have HbA1c less than 10%.
  • have UACR at least 100 mg/g
  • have eGFR between 20 and 60 ml/min/1.73 m2
Compensation Provided

You will be paid for your time. If you complete all study visits, you will be paid $900.

Contact Study Team

Interested? 👉 Click here to contact the study team

Contact Name: Anjali Kumari

Phone Number: 206-685-2072

Contact the Study Team - Sugar N Salt

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