Finerenone + Sotagliflozin for Cardio-Renal Complications in Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health \& Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.
Who Is on the Research Team?
Rodica Busui, MD, PhD
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with type 1 diabetes for over 10 years, who have certain markers of kidney or heart problems. Participants must also meet specific blood sugar and lab criteria, be on standard treatments unless not tolerated, and be able to follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive open label treatment based on their biomarker profiles for 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Finerenone
- Sotagliflozin
Trial Overview
The study is testing two drugs—Finerenone and Sotagliflozin—to see if they can help prevent or treat heart and kidney complications in people with long-term type 1 diabetes. Treatments are matched to participants based on their individual disease features.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Study participants with biomarker profiles that match with sotagliflozin will be adjudicated to this treatment arm. The clinically recommended dose of sotagliflozin is 200 mg per the manufacturer guidelines. The dose of 200 mg has a lower DKA risk and similar kidney benefits to the higher doses.
Study participants with biomarker profiles showing a match for finerenone will be adjudicated to this treatment arm. The clinically recommended dose for finerenone based on manufacturer guidelines is 20 mg once daily (oral) if screening eGFR is ≥60 mL/min/1.73 m2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
University of Michigan
Collaborator
Breakthrough T1D
Collaborator
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