Diabetes Islet Preservation Immune Treatment (DIPIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02586831|
Recruitment Status : Not yet recruiting
First Posted : October 26, 2015
Last Update Posted : June 23, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Experimental: Arm A
Participants in this group will receive Thymoglobulin, Aldesleukin, Adalimumab, and Exenatide over a period of 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®
2 mg administered subcutaneously weekly for up to 52 weeks.
Other Name: Bydureon®
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.
- 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)
- Proportion of regulatory T cells [ Time Frame: 1 Year Visit ]As measured from blood samples
- Hemoglobin A1c (HbA1c) levels [ Time Frame: Up to 18 months ]Measure of glycemic control as evaluated by HbA1c levels from blood samples
- Insulin dose [ Time Frame: Up to 18 months ]Measure of glycemic control as evaluated by insulin dose
- 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
- Incidence of immune response adverse events [ Time Frame: Up to 18 months ]Incidence of immune response adverse events as assessed by treating physician
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
|Contact: Rodolfo Alejandro, M.D.||(305) email@example.com|
|Contact: David A Baidal, M.D.||(305) firstname.lastname@example.org|
|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 email@example.com|
|Contact: David A Baidal, M.D. (305) 243-7740 firstname.lastname@example.org|
|Principal Investigator: Rodolfo Alejandro, M.D.|
|Principal Investigator: David A Baidal, M.D.|
|Principal Investigator:||Rodolfo Alejandro, M.D.||Diabetes Research Institute, University of Miami|