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Diabetes Islet Preservation Immune Treatment (DIPIT)

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ClinicalTrials.gov Identifier: NCT02586831
Recruitment Status : Not yet recruiting
First Posted : October 26, 2015
Last Update Posted : September 20, 2021
Sponsor:
Collaborator:
Diabetes Research Institute Foundation
Information provided by (Responsible Party):
Camillo Ricordi and Jay Skyler, University of Miami

Brief Summary:
To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Hypoglycemia Autoimmune Diseases Diabetes Mellitus Drug: Anti-Thymocyte Globulin (ATG) Drug: Interleukin 2 Drug: Exenatide Drug: Adalimumab Other: ATG Placebo Other: IL-2 Placebo Other: Adalimumab Placebo Other: Exenatide Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A

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.
Drug: Anti-Thymocyte Globulin (ATG)
2.5 mg/kg administered as two divided infusions of 0.5 mg/kg and 2 mg/kg on Days 1 and 2.
Other Name: Thymoglobulin

Drug: Interleukin 2
1 million IU per dose administered subcutaneously for 5 consecutive days on Days 10-14, and then every two weeks.
Other Name: Aldesleukin; IL-2 or Proleukin®

Drug: Exenatide
2 mg administered subcutaneously weekly for up to 52 weeks.
Other Name: Bydureon®

Drug: Adalimumab
50 mg administered subcutaneously once a month for 1 year.
Other Name: HUMIRA®

Placebo Comparator: Arm B
Participants in this group will receive the placebos for Thymoglobulin, Aldesleukin, Adalimumab, Exenatide, and Neulasta over a period of 52 weeks.
Other: ATG Placebo
ATG placebo mimicking Thymoglobulin administered intravenously.

Other: IL-2 Placebo
IL-2 placebo mimicking Aldesleukin administered subcutaneously.

Other: Adalimumab Placebo
Placebo mimicking Adalimumab administered subcutaneously.

Other: Exenatide Placebo
Placebo mimicking Exenatide administered subcutaneously.




Primary Outcome Measures :
  1. Simulated C-peptide AUC [ Time Frame: 1 Year Visit ]
    Endogenous insulin secretion as measured as stimulated C-peptide section Area Under the Curve (AUC) during a 4 hour mixed meal tolerance test (MMTT)

  2. Proportion of regulatory T cells [ Time Frame: 1 Year Visit ]
    As measured from blood samples


Secondary Outcome Measures :
  1. Hemoglobin A1c (HbA1c) levels [ Time Frame: Up to 18 months ]
    Measure of glycemic control as evaluated by HbA1c levels from blood samples

  2. Insulin dose [ Time Frame: Up to 18 months ]
    Measure of glycemic control as evaluated by insulin dose

  3. Mean daily plasma glucose levels [ Time Frame: Up to 18 months ]
    Measure of glycemic control as evaluated by the mean daily plasma glucose levels from blood samples

  4. Incidence of immune response adverse events [ Time Frame: Up to 18 months ]
    Incidence of immune response adverse events as assessed by treating physician



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet all of the following criteria to be eligible to participate in this study:

    1. Subject must be able to understand and provide informed consent.
    2. Males and females, 18-35 years of age.
    3. New onset T1D for no longer than 120 days at the time of randomization.
    4. Affected by T1D, according to ADA standard criteria, and confirmed by positivity of at least one T1D-associated autoantibody, to GAD65, IA-2, ZnT8, or insulin autoantibodies (if patient has been treated with insulin for less than 2 weeks).
    5. Being on insulin therapy.
    6. Stimulated C-peptide peak level >0.2 nmol/L at the baseline 1 visit MMTT.
    7. Female subjects of childbearing potential must have a negative pregnancy test upon study entry.
    8. Female (and male) subjects with reproductive potential must agree to use two FDA approved methods of birth control for the entire duration of the study.
    9. Adequate venous access to support study required blood draws.

Exclusion Criteria:

  • Potential participants must not meet any of the following exclusion criteria:

    1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
    2. BMI>30 Kg/m2.
    3. Contra-indications to ATG, GCSF, exenatide, etanercept and IL-2 (as per package insert, e.g., knowledge of hypersensitivity to drugs or its excipients).
    4. Uncompensated heart failure, fluid overload, myocardial infarction or liver disease or severe impairment of a vital organ within the last 6 weeks before enrollment.
    5. Any of the following laboratory findings: hemoglobin <10.0 g/dL; leukocytes <3,000/μL; neutrophils <1,500/μL; lymphocytes <800/μL; platelets <100,000/μL.
    6. Any sign or diagnosis of significant chronic active infection (e.g., hepatitis, tuberculosis, EBV, or CMV), or screening laboratory evidence consistent with a significant chronic active infection (such as positive for HIV, IGRA test for TB, or hepatitis B-C).
    7. Ongoing acute infections, e.g., acute respiratory tract urinary tract, or gastrointestinal tract infections.
    8. Ongoing or anticipated use of diabetes medications other than insulin.
    9. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening.
    10. Current or prior use of immunomodulators or systemic steroids in the last 2 months that could potentially affect diabetes or immunologic status.
    11. Recent recipient of any licensed or investigational live attenuated vaccine(s) within 6 weeks of randomization.
    12. Use of investigational drugs within 3 months of participation.
    13. Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic agents, or previous therapy less than 3 months from randomization.
    14. History or diagnosis of malignancy. Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exception of a history of localized basal cell carcinoma.
    15. Presence of an allograft.
    16. AST, ALT or Alkaline Phosphatase >2 times upper limit of normal or total bilirubin >1.5 times upper limit of normal.
    17. Current, diagnosed, mental illness or current, diagnosed or self-reported drug or alcohol abuse; or any situation that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
    18. Pregnancy or ongoing breastfeeding for women; unwillingness or inability of both females and males of childbearing age to use a reliable and effective form of contraception, for the entire duration of the study.
    19. Past or current medical problems, or findings from physical examination, or laboratory testing, that are not listed above which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586831


Contacts
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Contact: Rodolfo Alejandro, M.D. (305) 243-5324 ralejand@med.miami.edu
Contact: David A Baidal, M.D. (305) 243-7740 dbaidal@med.miami.edu

Locations
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United States, Florida
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Contact: Rodolfo Alejandro, M.D.    305-243-5324    ralejand@med.miami.edu   
Contact: David A Baidal, M.D.    (305) 243-7740    dbaidal@med.miami.edu   
Principal Investigator: Rodolfo Alejandro, M.D.         
Principal Investigator: David A Baidal, M.D.         
Sponsors and Collaborators
Camillo Ricordi and Jay Skyler
Diabetes Research Institute Foundation
Investigators
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Principal Investigator: Rodolfo Alejandro, M.D. Diabetes Research Institute, University of Miami
Publications:
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Responsible Party: Camillo Ricordi and Jay Skyler, Professors, University of Miami Miller School of Medicine and Director/Deputy Director, Diabetes Research Institute, University of Miami
ClinicalTrials.gov Identifier: NCT02586831    
Other Study ID Numbers: 20150856
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Hypoglycemia
Diabetes Mellitus, Type 1
Autoimmune Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Exenatide
Aldesleukin
Adalimumab
Interleukin-2
Thymoglobulin
Antilymphocyte Serum
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Hypoglycemic Agents
Anti-Obesity Agents
Incretins
Hormones