About 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.
Eligibility criteria
Qualifiers
presence of circulating T1D-associated autoantibodies, or
history of hospitalization for diabetic ketoacidosis, or
documented plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose >100 mg/dL)
Aged 18-75 years, inclusive
Disqualifiers
Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease
Use of GLP-1 receptor agonists if in use for less than 1 month and/or not on stable dose for at least 2 weeks at screening
Use of aldosterone inhibitors within 2 months prior to screening
Immunosuppressive medications within 3 months prior to screening
Trial design
Treatments tested in this trial
- Finerenone
- Sotagliflozin
Treatment groups
Sponsors and collaborators
Oregon Health and Science University
Lead sponsor
University of Michigan
Collaborator
Breakthrough T1D
Collaborator