Diabetes Islet Preservation Immune Treatment
Last updated on July 2021Recruitment
- 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