Precision T1D Platform - New Therapies for Cardio-Renal Complications

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOregon Health and Science University

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

57 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oregon Health and Science University

Lead sponsor

University of Michigan

Collaborator

Breakthrough T1D

Collaborator