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.
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
Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease
Use of any active platform treatment arms outside study assignment within 2 months prior to screening. See Appendix A for active treatment arms
Current use of GLP-1 receptor agonists or other non-glucose lowering agent
Use of aldosterone inhibitors within 2 months prior to screening
Parallel
Finerenone
DrugEach treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion.
Sotagliflozin
DrugEach treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion.
Markers of Renal Health [Safety and Tolerability]
The primary efficacy endpoints are measures of early (week 26) outcomes on markers of renal health, defined as the percent change from baseline to week 26 in UACR.
Markes of Cardio Health [Safety and Tolerability]
The primary efficacy endpoints are measures of early (week 26) outcomes on markers of cardio health as defined by the percent change from baseline to week 26 in NT-proBNP.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary safety endpoints are defined as incidence of serious adverse events, adverse events and clinically significant abnormal laboratory tests.
Immediate Outcomes of Renal Health (week 6)
The secondary endpoints are measures of immediate outcomes on markers of renal health as defined by changes from baseline to week 6 in UACR.
Immediate Outcomes of Cardio Health (week 6)
The secondary endpoints are measures of immediate outcomes on markers of cardio health as defined by changes from baseline to week 6 in NT-proBNP.
Immediate (week 6) and Early (week 26) Outcomes of Nephron Function Failure
The secondary endpoints are measures of immediate outcomes on markers of renal function failure as defined by changes from baseline to week 6 and from baseline to week 26 in eGFR.
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Oregon Health and Science University
Lead sponsor
University of Michigan
Collaborator
Breakthrough T1D
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
