Study of Antithymocyte Globulin for Treatment of New-onset T1DM (START)

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00515099
First received: August 10, 2007
Last updated: April 10, 2015
Last verified: April 2015
Results First Received: February 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: New-onset Type 1 Diabetes Mellitus
Interventions: Drug: Antithymocyte globulin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited during an approximate 40-month accrual period. Initially 66 subjects were planned, however enrollment closed early at 58 subjects on June 30, 2011 secondary to slow accrual (planned 30-month accrual period).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects ages 12 to 35 years who were first diagnosed with type 1 diabetes mellitus (T1DM) within 100 days of enrollment.

Reporting Groups
  Description
Antithymocyte Globulin This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
Placebo This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.

Participant Flow:   Overall Study
    Antithymocyte Globulin     Placebo  
STARTED     38     20  
COMPLETED     35     16  
NOT COMPLETED     3     4  
Lost to Follow-up                 0                 4  
Withdrawal by Subject                 2                 0  
IRB Recommendation                 1                 0  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)   [ Time Frame: Baseline (Pre-treatment initiation), Month 12 ]

2.  Secondary:   4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)   [ Time Frame: Baseline (Pre-treatment initiation), Month 12 ]

3.  Secondary:   Insulin Use in Units Per Kilogram Body Weight Per Day   [ Time Frame: Baseline (Pre-treatment), Months 12 and 24 ]

4.  Secondary:   Number of Participants Who Are Exogenous-Insulin-Free   [ Time Frame: Baseline (Pre-treatment), Months 12 , 18, and 24 ]

5.  Secondary:   Number of Participants With Major Hypoglycemic Event(s) Post Treatment Randomization/Initiation   [ Time Frame: Baseline (Pre-treatment), Months 12 , and 24 ]

6.  Secondary:   2-Hour and 4-Hour C-peptide Area Under the Curve (AUC) Results in Response to Standardized Mixed Meal Tolerance Test (MMTT)   [ Time Frame: Baseline (Pre-treatment), Month 24 ]

7.  Secondary:   Hemoglobin A1c   [ Time Frame: Baseline (Pre-treatment), Months 12 and 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Enrollment for this trial was closed at 58 participants and did not meet the planned sample size of 66 participants due to slow accrual.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00515099     History of Changes
Other Study ID Numbers: DAIT ITN028AI
Study First Received: August 10, 2007
Results First Received: February 10, 2014
Last Updated: April 10, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board