150 Participants Needed

Sotagliflozin for Diabetic Kidney Disease

(SUGARNSALT Trial)

Recruiting at 20 trial locations
CM
EC
Overseen ByEmily Collins
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Alessandro Doria
Must be taking: Insulin, RASB
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, 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 T1D and DKD.

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 any SGLT inhibitors in the past 2 months or be on certain other medications like dual RASB therapy or GLP-1 receptor agonists unless you've been on a stable dose for at least 3 months.

Is sotagliflozin safe for humans?

Sotagliflozin is generally well tolerated in humans, but it carries a risk of diabetic ketoacidosis (a serious condition where the body produces high levels of blood acids called ketones). This risk has been noted in studies for both type 1 and type 2 diabetes.12345

How is the drug sotagliflozin unique for diabetic kidney disease?

Sotagliflozin is unique because it is a dual inhibitor of sodium-glucose co-transporters 1 and 2, which means it works by both delaying glucose absorption in the gut and reducing glucose reabsorption in the kidneys. This dual action can help manage blood sugar levels and potentially benefit kidney function in patients with diabetes.12356

What data supports the effectiveness of the drug Sotagliflozin for diabetic kidney disease?

Research shows that Sotagliflozin, a drug that helps control blood sugar by blocking certain proteins, has been effective in improving kidney function in people with type 2 diabetes and chronic kidney disease. It has also been shown to improve blood sugar control in type 1 diabetes, although it carries a risk of diabetic ketoacidosis (a serious diabetes complication).12356

Who Is on the Research Team?

Pharmacology and Toxicology

David Cherney

Principal Investigator

University of Toronto

AD

Alessandro Doria, MD PhD MPH

Principal Investigator

Joslin Diabetes Center

MM

Michael Mauer, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for people with Type 1 Diabetes who also have moderate to advanced diabetic kidney disease. Participants should be willing to follow a strict program to prevent diabetic ketoacidosis, including education and regular monitoring. Those at risk of DKA or unable to adhere to the prevention plan are excluded.

Inclusion Criteria

HbA1c <10% at screening
Willing and able to comply with schedule of events and protocol requirements, including written informed consent, and willing to wear a continuous glucose monitoring (CGM) device for the entire duration of the study
I am on standard treatment for my condition, including RASB, unless I cannot tolerate it.
See 4 more

Exclusion Criteria

Any condition that may render the patient unable to comply with study requirements and/or complete the study
I am currently using anti-TNF alpha medications.
I have had a severe diabetic complication in the last 3 months or more than once in the last year.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Diabetes care is standardized and education on monitoring and minimizing DKA is implemented

8 weeks

Treatment

Participants receive either sotagliflozin or placebo for 3 years with continuous glucose monitoring and DKA risk mitigation

156 weeks
Regular visits for monitoring (weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140, 156)

Wash-out

Participants undergo a 2-month period without treatment to assess the wash-out effects

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sotagliflozin
Trial Overview The study tests if Sotagliflozin can slow down kidney function decline in Type 1 Diabetes patients with kidney disease. Half will receive Sotagliflozin; the other half a placebo, randomly assigned. The trial includes a DKA prevention program and spans over three years plus two months without treatment.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: SotagliflozinActive Control1 Intervention
Oral sotagliflozin at a dose of 200 mg (one tablet) per day for three years followed by a 2-month wash-out period.
Group II: PlaceboPlacebo Group1 Intervention
Oral tablets similar to sotagliflozin tablets but containing no active drug (one tablet per day for three years followed by a 2-month wash-out period).

Sotagliflozin is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Zynquista for:
  • Type 1 diabetes mellitus
🇺🇸
Approved in United States as Inpefa for:
  • Heart failure
  • Type 2 diabetes mellitus
  • Chronic kidney disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alessandro Doria

Lead Sponsor

Trials
3
Recruited
720+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

University Health Network, Toronto

Collaborator

Trials
1,555
Recruited
526,000+

University of Alberta

Collaborator

Trials
957
Recruited
437,000+

DexCom, Inc.

Industry Sponsor

Trials
151
Recruited
35,700+
Kevin Sayer profile image

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane profile image

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Institut de Recherches Cliniques de Montreal

Collaborator

Trials
72
Recruited
10,300+

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials
237
Recruited
142,000+

Lexicon Pharmaceuticals

Industry Sponsor

Trials
67
Recruited
24,400+

Dr. Mike Exton

Lexicon Pharmaceuticals

Chief Executive Officer

PhD in Neuroscience from the University of Newcastle and PhD in Immunology from the University of Essen, Germany

Dr. Craig Granowitz

Lexicon Pharmaceuticals

Chief Medical Officer since 2021

MD

University of Toronto

Collaborator

Trials
739
Recruited
1,125,000+

Published Research Related to This Trial

Sotagliflozin, a dual SGLT 1 and 2 inhibitor, has been shown to significantly reduce HbA1c levels in patients with type 1 diabetes when used alongside optimized insulin therapy, indicating its efficacy as a treatment option.
Despite its benefits, sotagliflozin is associated with a higher risk of diabetic ketoacidosis compared to placebo, which raised safety concerns during the FDA review process, leading to its approval only in the EU for specific patients.
Sotagliflozin: First Global Approval.Markham, A., Keam, SJ.[2020]
In a phase 3 trial involving 787 adults with type 2 diabetes and stage 3 chronic kidney disease, sotagliflozin 400 mg significantly reduced HbA1c levels compared to placebo after 26 weeks, while the 200 mg dose did not show significant efficacy.
Both doses of sotagliflozin led to reductions in urine albumin-creatinine ratio (UACR) in patients with at least A2 albuminuria, indicating potential renal benefits, although these changes were not sustained at 52 weeks.
Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease.Cherney, DZI., Ferrannini, E., Umpierrez, GE., et al.[2023]
Sotagliflozin, a new medication for diabetes, was found to be safe for renal function, showing no significant adverse effects on kidney health in a review of 14 studies involving 17,574 participants, including those with existing renal impairment.
The drug did not significantly change urinary albumin excretion or the risk of composite renal events, indicating that while it is safe, more research is needed to fully understand its effectiveness in preventing diabetic kidney disease.
Effect of the dual sodium-glucose co-transporter-1 and -2 inhibitor sotagliflozin on renal outcomes in type 1 diabetes and type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.Bantounou, MA., Sardellis, P., Thuemmler, R., et al.[2023]

Citations

Sotagliflozin: First Global Approval. [2020]
Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease. [2023]
Effect of the dual sodium-glucose co-transporter-1 and -2 inhibitor sotagliflozin on renal outcomes in type 1 diabetes and type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. [2023]
Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment. [2022]
Sotagliflozin: A Review in Type 1 Diabetes. [2020]
Severe Ketoacidosis Associated with Canagliflozin (Invokana): A Safety Concern. [2022]
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