Sotagliflozin for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to:
1. Evaluate how ketone metrics differ between participants with mild to moderate chronic kidney disease and those with normal renal function in three time periods.
2. Identify potentially modifiable ketosis risk factors.
3. Use continuous glucose monitoring (CGM) and continuous ketone monitoring (CKM) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors.
4. Gather information on how participants and clinicians like and use the CGM/CKM reports.
Participants will be asked to:
* Meet with study investigators to determine if they are eligible
* Sign written informed consent
* Take a pregnancy test, if applicable
* Have blood taken to assess kidney function and hemoglobin A1c
* Take the study medication, following the study team instructions
* Wear the study provided sensor throughout participation.
* Complete 5 in person visits, and 11 phone check ins over a nine-month period
* Provide feedback on the usefulness of CGM/CKM reports
Who Is on the Research Team?
Richard Bergenstal, MD
Principal Investigator
HealthPartners/Park Nicollet International Diabetes Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with Type 1 Diabetes and mild to moderate kidney disease who use insulin pumps or injections. They must speak English, have not used SGLT2i medications before, can wear monitoring devices, and commit to the study schedule.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sotagliflozin 200 mg/d for 3 months, with an option to increase to 400 mg/d based on glycemic control and kidney function
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in ketone levels and episodes of ketosis
Extension
Participants may continue to use the CGM/CKM reports and provide feedback on their usefulness
What Are the Treatments Tested in This Trial?
Interventions
- Sotagliflozin
Trial Overview
The trial tests if continuous ketone monitoring helps reduce diabetic ketoacidosis risk when starting Sotagliflozin in Type 1 Diabetics with kidney issues. It involves blood tests, sensor wearing, medication adherence, and regular check-ins over nine months.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
In this single arm trial, all patients will be started on sotagliflozin at a dose of 200mg/d. After 3 months of sotagliflozin 200 mg/d, patients who do not achieve good glycemic control (TIR \>60%) and who have moderate or no CKD (eGFR \>60) will be offered the option to increase sotagliflozin to 400mg/d. All other participants will continue taking 200 mg sotagliflozin daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
HealthPartners Institute
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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