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New treatment option for Diabetic Nephropathies
Official title Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
ClinicalTrials.gov ID: NCT06217302
What this study is testing
What is Sotagliflozin?
Sotagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic nephropathies.
Also referred to as INPEFA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.
- Duration of T1D ≥ 8 years;
- eGFR based on serum creatinine and cystatin c (2021 serum creatinine-cystatin C CKD-EPI equation) between 20 and 60 ml/min/1.73 m2 at screening (with...
- a. First morning void urinary albumin creatinine ratio (UACR) ≥200 mg/g at Screening or on repeat measurement within 4 weeks from the first one, or...
- HbA1c at screening \<10% (with the option of a second HbA1c measurement within 4 weeks from the first one if the HbA1c was ≤10.2%);
You likely can't join if
- Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
- Use of automated insulin delivery devices that are not approved by health regulatory agencies, or used in ways that do not align with manufacturer...
- Use of any SGLT inhibitor in the previous 2 months;
- Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);
- Use of GLP-1 receptor agonists and other non-insulin glucose-lowering agents if not on stable dose for \> 2 months at screening (patients can be...
- Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;
See the full eligibility criteria
- Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.
- Duration of T1D ≥ 8 years;
- eGFR based on serum creatinine and cystatin c (2021 serum creatinine-cystatin C CKD-EPI equation) between 20 and 60 ml/min/1.73 m2 at screening (with the option of a second eGFR measurement within 4 weeks from the first...
- a. First morning void urinary albumin creatinine ratio (UACR) ≥200 mg/g at Screening or on repeat measurement within 4 weeks from the first one, or b. First morning void urinary UACR ≥100 mg/g at Screening or on repeat...
- HbA1c at screening \<10% (with the option of a second HbA1c measurement within 4 weeks from the first one if the HbA1c was ≤10.2%);
- Receiving standard of care, including renin angiotensin system blockers (RASB) at a clinically appropriate dose, unless contraindicated or not tolerated.
- 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.
- a. Blood pressure ≤155/95 mmHg at screening, or b. BP ≤155/95 mmHg at the end of the run-in period, or c. consistent BP ≤155/95 mmHg on home monitoring during the run-in period, as determined by study site investigator...
- Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
- Use of automated insulin delivery devices that are not approved by health regulatory agencies, or used in ways that do not align with manufacturer recommendations;
- Use of any SGLT inhibitor in the previous 2 months;
- Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);
- Use of GLP-1 receptor agonists and other non-insulin glucose-lowering agents if not on stable dose for \> 2 months at screening (patients can be rescreened after being on stable dose for \> 2 months);
- Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;
- Known allergies, hypersensitivity, or intolerance to SOTA;
- History of ≥3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;
- History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state within 3 months of screening OR \>1 episode of DKA or non-ketotic hyperosmolar state within 12 months of screening;
- Blood beta-hydroxybutyrate (BHB) \>0.6 mmol/L for \>2 hours on \>2 occasions during the Run-in period;
- Inadequate beta hydroxybutyrate (BHB) testing (\<50% of the prescribed measurements) during Run-in;
- History of primary renal glycosuria;
- History of biopsy-proven non-diabetic chronic kidney disease (CKD);
- History of kidney transplant or currently on chronic dialysis;
- Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and/or aspartate...
- History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;
- Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of...
- Illicit drug abuse within 6 months of screening;
- Heavy alcohol use (for men, 5 drinks or more on any day or 15 drinks or more per week; for women, 4 drinks or more on any day or 8 drinks or more per week);
- Participation in another treatment clinical research study within 30 days of screening;
- Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;
- Presence of a clinically significant medical history, physical examination, or laboratory finding that may interfere with any aspect of study conduct or interpretation of results;
- Any condition that may render the patient unable to comply with study requirements and/or complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Aurora, Colorado, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Syracuse, New York, United States
- The Bronx, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
- Spokane, Washington, United States
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Aurora, Colorado, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.