Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia

Launched by STENO DIABETES CENTER COPENHAGEN · Nov 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called sotagliflozin on kidney health in people with type 1 diabetes who also have chronic kidney disease. The main goal is to see if taking this medication for 12 weeks can improve kidney oxygen levels and overall kidney function. Researchers will also look at how this treatment may affect heart function and various health markers found in blood and urine.

To participate in the trial, you need to be at least 18 years old and have a diagnosis of type 1 diabetes, along with certain kidney health requirements, such as having albuminuria (an indicator of kidney damage). The study will include about 69 participants from two locations, and everyone will receive either the sotagliflozin or a placebo (a non-active pill) without knowing which one they are taking. Throughout the study, participants will undergo imaging tests and provide blood and urine samples to help assess the effects of the treatment. If you meet the eligibility criteria and choose to participate, your involvement will help researchers learn more about ways to protect kidney health in individuals with type 1 diabetes.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Persons ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset \<40 years; permanent insulin treatment initiated within 1 year of diagnosis)
• • 2. Albuminuria: UACR \> 100 mg/g (in ≥2 out 3 morning spot urine collections prior to randomization)
• • 3. estimated Glomerular Filtration Rate(eGFR) ≥25 and \< 75 ml/min/1.73m2
• • 4. Participants must be on stable renin-angiotensin system blocking treatment 4 weeks before start of study drug and throughout study duration.
• • 5. Able to understand the written participant information and give informed consent
• Exclusion Criteria:
• • 1. Non-diabetic kidney disease indicated by medical history and/or laboratory findings.
• • 2. eGFR\< 25 ml/min/1.73m2, dialysis or kidney transplantation.
• • 3. Previous diabetic ketoacidosis, except at debut.
• • 4. Dysregulated diabetes (HbA1c \> 85 mmol/mol)
• • 5. Decreased awareness or unawareness
• • 6. Pregnancy, lactating or with a wish of pregnancy within the next year
• • 7. Low carbohydrate diet
• • 8. Receiving therapy with an SGLT inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT inhibitor.
• • 9. New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
• • 10. Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
• • 11. The receipt of any investigational product 90 days prior to this trial
• • 12. Unable to participate in study procedures
• • 13. Any clinically significant disorder, except for conditions associated with type 1 diabetes, which in the Investigators opinion could interfere with the results of the trial
• • 14. Participation in another intervention study
• • 15. Exclusion criteria for MRI: known claustrophobia, known chronic lung disease, surgery within past 6 weeks or having foreign bodies of metal in the body (e.g. pacemaker, metal plates, metal screws)
• • 16. Recurrent urogenital infections.