Phase 3 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have had Type 1 diabetes for at least 8 years and were started on insulin within one year of being diagnosed.
• People whose kidneys are working at a reduced but specific level — measured by a blood test called eGFR, with a result between 20 and 60 on a standard scale (confirm with trial site if result falls just outside this range, as a second test may be allowed).
• People whose urine shows a certain level of protein leakage (albumin), measured by a test called UACR, meeting specific thresholds depending on current kidney medication use (confirm exact thresholds with trial site).
• People whose blood sugar control (HbA1c) is below 10% at screening (a second test within 4 weeks may be allowed if the first result is close to this level).
• People who are already taking a blood pressure and kidney-protecting medication called a renin angiotensin system blocker (RASB), unless their doctor has determined it is not suitable for them.
• People whose blood pressure is at or below 155/95 mmHg at screening or during a lead-in period before the trial begins.
• People who are willing and able to follow all trial requirements, including signing a consent form and wearing a continuous glucose monitor (a small sensor that tracks blood sugar levels) for the entire study.

Who may not be able to join:

• People who have Type 2 diabetes, a rare inherited form of diabetes, or diabetes caused by a pancreatic condition.
• People who use an automated insulin delivery device that has not been approved by health regulators, or who use such a device in a way that does not follow the manufacturer's instructions.
• People who have used a type of medication called an SGLT inhibitor in the 2 months before screening.
• People who are taking two different types of blood pressure/kidney medications from the RASB class at the same time (certain other medications such as spironolactone, eplerenone, or finerenone used alongside a single RASB are permitted).
• People who have recently changed the dose of a GLP-1 receptor agonist or other non-insulin diabetes medication and have not been on a stable dose for more than 2 months before screening.
• People who are currently taking anti-TNF alpha biologic medications (a type of medication used for immune and inflammatory conditions).
• People with a known allergy or intolerance to the study drug (SOTA).
• People who have had 3 or more severe low blood sugar episodes requiring help from another person in the 3 months before screening.
• People who have had a serious diabetic emergency called diabetic ketoacidosis (DKA) or a hyperosmolar state within the past 3 months, or more than one such episode in the past 12 months.
• People who show elevated ketone levels (a substance called beta-hydroxybutyrate) in their blood on more than 2 occasions during the lead-in period before the trial.
• People who do not complete enough of the required ketone testing during the lead-in period.
• People with a personal history of a kidney condition called primary renal glycosuria.
• People with a history of kidney disease confirmed by biopsy that is not caused by diabetes.
• People who have had a kidney transplant or are currently receiving dialysis.
• People with a history of serious liver disease, including cirrhosis, certain liver complications, or abnormal liver blood test results above specified levels at screening.
• People with a history of severe HIV/AIDS or a seriously weakened immune system.
• People who have received treatment for cancer within the year before screening (some early-stage or fully treated cancers may be exceptions — confirm with trial site).
• People who have used illicit drugs in the 6 months before screening.
• People who drink heavily (as defined by specific weekly or daily alcohol limits that differ for men and women — confirm with trial site).
• People who are currently participating in another interventional clinical trial, or who have done so within 30 days of screening.
• People who are pregnant, breastfeeding, or unwilling to use contraception during the trial.
• People with any other significant medical condition, finding, or circumstance that the trial team determines could interfere with the study or their ability to participate safely.

Important: Always verify eligibility with the trial site directly before applying.