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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: September 15, 2016
Last verified: September 2016
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat

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.
Total Total of all reporting groups

Baseline Measures
   Antithymocyte Globulin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   20   58 
Age 
[Units: Participants]
     
<=18 years   19   10   29 
Between 18 and 65 years   19   10   29 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 19.4  (6.6)   20.5  (7.1)   19.8  (6.7) 
Age, Customized 
[Units: Participants]
     
12 -15 Years   13   6   19 
16 - 21 Years   13   6   19 
22 - 35 Years   12   8   20 
Gender 
[Units: Participants]
     
Female   14   9   23 
Male   24   11   35 
Region of Enrollment 
[Units: Participants]
     
United States   38   20   58 


  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


  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: September 15, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board