Are You Interested in Participating in a Research Study at OHSU to Determine if Sotagliflozin can Help Slow Kidney Function Decline in People with Type 1 Diabetes?
The SugarNSalt Trial, is currently enrolling participants with Type 1 Diabetes and moderate to severe diabetic kidney disease at Oregon Health and Science University (OHSU) under the direction of site physician Dr. Rodica Busui. This trial is determining if an investigational oral medication called Sotagliflozin (SOTA) can help slow kidney function decline in patients with type 1 diabetes. This trial is being funded by Breakthrough T1D and will act as an aid in determining future treatments and improving quality of life for patients with diabetic kidney disease.
SOTA is a drug in the family of medications called SGLT1 and SGLT2 (sodium/glucose transport) inhibitors and is currently approved by the FDA to reduce the risk of being admitted to the hospital due to heart failure in persons with type 2 diabetes and other conditions. Some studies have shown that drugs like SOTA may also slow the progression of kidney disease in people with and without diabetes.
THE STUDY
Aim
The goal of this study is to determine whether SOTA can help slow the progression of kidney function decline in people with type 1 diabetes.
Inclusion Criteria
You may be eligible to participate if you are:
- Diagnosed with type 1 diabetes for at least 8 years and continuously treated with insulin
- Between the ages of 18 and 75 years
- Have been told by your doctor that you have diabetic kidney disease or protein in your urine
What Is Involved?
- The study consists of 18 clinic visits and 1 phone visit over 3 years.
- You will be randomized to take SOTA or an inactive pill that looks like SOTA once daily for the duration of the study.
- Study visits include blood and urine sampling, medical history review, physical exam and ECG, and surveys.
- Participants will continuously wear a Continuous Glucose Monitoring (CGM) device and periodically measure blood ketones by finger sticks.
- Participants will receive $50 per study visit except for one virtual visit.
Contact Information
To discuss this study or find out if you’re eligible, please contact OSHU study staff (Aly Carlson or Krista Metas) by phone or email.
Oregon Health and Science University | Portland, Oregon
Aly Carlson: 971-610-3005
Krista Metas: 971-484-5758
Email: sugarnsalt@ohsu.edu
OHSU IRB#: 27158
University of Washington is an additional site for this study. If you live closer to Seattle and are interested in this study, please contact Paul Ly, lypaul@uw.edu, (206) 685-2007.
