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TNF-alpha inhibitor

Immune Preservation Therapy for Type 1 Diabetes (DIPIT Trial)

Phase 1 & 2

Waitlist Available

Led By Rodolfo Alejandro, M.D.

Research Sponsored by Camillo Ricordi and Jay Skyler

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must be able to understand and provide informed consent

Males and females, 18-35 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year visit

Awards & highlights

DIPIT Trial Summary

This trial will compare the effect of a combination therapy vs. placebo on insulin secretion and regulatory T cells in patients 1 year after treatment.

Who is the study for?

Adults aged 18-35 with Type 1 Diabetes, on insulin therapy, and a certain level of C-peptide. They must not have had diabetes for more than 120 days at randomization, be able to consent, use two forms of birth control if applicable, and meet specific health criteria excluding pregnancy, breastfeeding, recent vaccines or drug trials, infections or chronic diseases.Check my eligibility

What is being tested?

The trial is testing whether combinational therapy (Anti-Thymocyte Globulin (ATG), Interleukin 2 (IL-2), Exenatide) versus placebo affects insulin secretion in Type 1 Diabetes patients after one year. It also examines the treatments' impact on immune system regulation by measuring T cells.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to medication components like ATG or IL-2; changes in blood sugar levels due to Exenatide; increased risk of infection from immunosuppression; and possible organ inflammation.

DIPIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study and can give my consent.

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I am between 18 and 35 years old.

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I have Type 1 Diabetes and tested positive for specific diabetes-related autoantibodies.

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I am of childbearing age and have a negative pregnancy test.

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I am currently taking insulin.

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I agree to use two approved birth control methods during the study.

DIPIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of regulatory T cells

Simulated C-peptide AUC

Secondary outcome measures

Hemoglobin A1c (HbA1c) levels

Incidence of immune response adverse events

Insulin dose

+1 more

DIPIT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment4 Interventions

Participants in this group will receive Thymoglobulin, Aldesleukin, Adalimumab, and Exenatide over a period of 52 weeks. Anti-Thymocyte Globulin (ATG or Thymoglobulin®) will be administered at a dose of 2.5mg/kg (2 infusions, 0.5 and 2mg/kg) Days 1 and 2 Adalimumab (Humira®) will be administered at a dose of 50 mg every month, for 1 year Low-dose Interleukin 2 (Aldesleukin; IL-2 or Proleukin®) will be administered 1 million IU/dose; 5 consecutive days (days 10-14), & then every 2 weeks, for 52 weeks Exenatide (Bydureon®): 2 mg SC weekly up to 52 weeks.

Group II: Arm BPlacebo Group4 Interventions

Participants in this group will receive the placebos for Thymoglobulin, Aldesleukin, Adalimumab, Exenatide, and Neulasta over a period of 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anti-Thymocyte Globulin (ATG)

2014

Completed Phase 2

~90

Interleukin 2

2014

Completed Phase 4

~330

Exenatide

2010

Completed Phase 4

~2970

Adalimumab

2013

Completed Phase 4

~6480

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Camillo Ricordi and Jay SkylerLead Sponsor

Diabetes Research Institute FoundationOTHER

9 Previous Clinical Trials

142 Total Patients Enrolled

2 Trials studying Diabetes

18 Patients Enrolled for Diabetes

Rodolfo Alejandro, M.D.Principal InvestigatorDiabetes Research Institute, University of Miami

3 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Diabetes Research Study Groups: Arm A, Arm B

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation have an age limit and, if so, is it higher than 85 years?

"This medical trial is searching for participants between 18 and 35 years of age."

Answered by AI

Can you elaborate on the previous research conducted with Interleukin 2?

"Presently, there are 182 clinical studies being conducted for Interleukin 2. 31 of those trials have made it to Phase 3 status. While the majority of research is centered in Tampa, Florida, 2811 locations across America are also running experiments with this medication."

Answered by AI

What is the aggregate of participants in this medical research?

"Sadly, this clinical trial has ceased recruitment. It was initially posted on December 1st 2023 and lastly amended on November 5th 2022. If you are hunting for other options, there currently exists 1336 studies seeking participants with autoimmune diseases and 182 trials enrolling patients who require Interleukin 2 therapy."

Answered by AI

What are the aims of this experiment?

"Over the course of 1 year, this study will primarily assess Proportion of regulatory T cells. Additionally, researchers are measuring Insulin dose (as a measure of glycemic control), Incidence of immune response adverse events (assessed by treating physician) and Hemoglobin A1c levels (to evaluate glycemic control from blood samples)."

Answered by AI

What clinical conditions can be treated with Interleukin 2?

"Interleukin 2 is commonly administered to combat metastatic melanoma. It may also be prescribed for treating kidney diseases, psoriatic arthritis, and muscular dystrophy."

Answered by AI

Is enrollment for this experiment still open?

"Clinicaltrials.gov reveals that this medical experiment, which was first made available on December 1st 2023 and last updated November 5th 2022, is not actively recruiting patients. However, there are 1518 studies currently seeking participants."

Answered by AI

What profile of individuals are ideal participants for this medical experiment?

"Qualified participants for this medical trial should be between 18 and 35 years old and suffer from an autoimmune disease. Approximately 45 individuals are required to complete the study."

Answered by AI