Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Autoimmune Diseases
  • Diabetes Mellitus
  • Diabetes Mellitus - Type 1
  • Hypoglycemia
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 35 years
Gender
Both males and females

Description

There is a critical need to test therapies that afford long-lasting immunomodulation through the combined use of short courses of depleting agents, more chronic use of drugs that promote immunoregulation and critically control the rebounding effector populations, together with interventions that que...

There is a critical need to test therapies that afford long-lasting immunomodulation through the combined use of short courses of depleting agents, more chronic use of drugs that promote immunoregulation and critically control the rebounding effector populations, together with interventions that quell inflammation and support beta cell function and glucose metabolism. Such combined regimens would rely on lower doses of many of these agents, for increased safety and tolerability. Here, we propose a combinatorial regimen based on the administration of drugs that are already FDA approved and marketed, all of which have been used in clinical trials in patients with T1D, alone or in some combination. This trial will test if the regimen proposed, for the first time combining all of these agents, will be successful in preserving insulin secretion in recent onset type 1 diabetes.

Tracking Information

NCT #
NCT02586831
Collaborators
Diabetes Research Institute Foundation
Investigators
Principal Investigator: Rodolfo Alejandro, M.D. Diabetes Research Institute, University of Miami