Sotagliflozin for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called sotagliflozin to help people with type 1 diabetes manage their condition safely, particularly those with mild to moderate kidney problems. Researchers aim to determine if this treatment can reduce the risk of ketoacidosis, a dangerous condition that can occur in people with diabetes. Participants will use continuous monitoring devices to track glucose and ketone levels. This trial suits individuals who have had type 1 diabetes for at least three months, use insulin, and have kidney function that is not severely impaired. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important diabetes research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used certain diabetes medications or corticosteroids recently. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that sotagliflozin is generally safe for people with diabetes. Studies have found that it helps lower blood sugar, body weight, and blood pressure in people with type 1 diabetes, similar to those without chronic kidney disease (CKD). Another study noted that side effects, such as genital infections, were manageable for patients.
However, an FDA advisory panel raised concerns about using it for blood sugar control in people with type 1 diabetes who also have CKD, voting against its approval for this use. This suggests there may still be some risks that require further understanding.
While sotagliflozin has shown promise, it's important to consider both the potential benefits and risks before deciding to join a trial.12345Why do researchers think this study treatment might be promising for diabetes?
Sotagliflozin is unique because it offers a dual mechanism of action for managing Type 1 Diabetes by inhibiting both SGLT1 and SGLT2 proteins. Most current treatments focus on insulin therapy or other glucose-lowering medications that don't directly target these proteins. Sotagliflozin not only helps lower blood sugar but also may improve time in range (TIR) for blood glucose levels, which is a key measure of glycemic control. Researchers are excited because this dual action could lead to better overall glucose management and potentially fewer complications for patients.
What evidence suggests that sotagliflozin might be an effective treatment for type 1 diabetes?
Research has shown that sotagliflozin can help manage type 1 diabetes, even for those with chronic kidney disease (CKD). Studies have found that this treatment lowers HbA1c levels, which measure blood sugar control, and can also lead to weight loss and lower blood pressure. In one study, 44% of people taking 400 mg of sotagliflozin saw improvements, compared to 34% taking 200 mg, and 22% with a placebo. In this single-arm trial, all participants will start with 200 mg of sotagliflozin daily. After 3 months, those who do not achieve good glycemic control and have moderate or no CKD will have the option to increase to 400 mg daily. Another study showed that adding sotagliflozin to insulin therapy reduced A1c by 0.46, which can help lower the risk of diabetes-related complications and slow CKD progression. The treatment is considered safe, with most side effects being mild and manageable.12678
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
Citations
Efficacy and Safety of Sotagliflozin in Patients with Type 1 ...
Sotagliflozin treatment had similar HbA1c, body weight, and systolic BP lowering effects as in participants with type 1 diabetes without CKD.
The safety of sotagliflozin in the therapy of diabetes ...
This meta-analysis showed that the adverse events of sotagliflozin were tolerable to patients with DM, in terms of the incidence of genital mycotic infection.
Cost-effectiveness analysis model for sotagliflozin ...
Glycemic control can reduce diabetes-related complications and slow CKD progression. Adding sotagliflozin to insulin therapy reduced A1c by 0.46 ...
Effects of Sotagliflozin Added to Insulin in Patients with ...
In phase 2 trials, sotagliflozin, empagliflozin, and canagliflozin were associated with significant decreases in the glycated hemoglobin level ...
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diatribe.org
diatribe.org/diabetes-medications/type-1-diabetes-pill-newest-sotagliflozin-trial-resultsA Type 1 Diabetes Pill? Newest Sotagliflozin Trial Results
44% of people taking 400 mg sotagliflozin benefitted, compared to 34% of those taking 200 mg of sotagliflozin and only 22% in the placebo group. People taking ...
Endocrinologic and Metabolic Drugs Advisory
Do the available data demonstrate that the benefits of sotagliflozin outweigh the risks for the indication of improved glycemic control in a ...
NCT06217302 | Sotagliflozin to Slow Kidney Function ...
This study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with ...
FDA panel votes against sotagliflozin for glucose control in ...
An FDA advisory panel voted 3-11 against approving sotagliflozin for glucose control in type 1 diabetes and CKD. The panel determined that ...
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