Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)
Oregon Health and Science University
Summary
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.
Description
This is a multicenter, open label pilot platform study to evaluate the impact of allocating patients with T1D and early signs of HF/DKD to targeted therapies based on their disease pathway activation signatures. The hypothesis is that stratifying T1D patients by molecularly-defined endophenotypes enables the use of targeted therapies that can more effectively prevent or slow cardio-renal complications. There is no randomized allocation to treatment arms; rather, the eligible participant's clinical and biomarker data will be reviewed by the Molecular T1D Board (see section XX) which will adjud…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of T1D, defined as hyperglycemia requiring treatment with insulin within one year from diagnosis or, if the onset was after age 35 years, documentation of the presence of hyperglycemia and one or more of the following: 1. presence of circulating T1D-associated autoantibodies, or 2. history of hospitalization for diabetic ketoacidosis, or 3. documented plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose \>100 mg/dL) 2. Aged 18-75 years, inclusive 3. T1D duration \>10 years 4. HbA1c: 7-10% 5. Meets one of th…
Interventions
- DrugFinerenone
Each 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.
- DrugSotagliflozin
Each 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.
Locations (2)
- University of MichiganAnn Arbor, Michigan
- Oregon Health & Science UniversityPortland, Oregon