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Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Juvenile Diabetes Research Foundation
American Diabetes Association
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00505375
First received: July 20, 2007
Last updated: July 7, 2016
Last verified: July 2016
Results First Received: May 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: CTLA-4 Ig
Other: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CTLA-4 Ig

Intravenous infusions of CTLA-4 Ig

CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses

Placebo

Intravenous infusions of placebo

Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses


Participant Flow:   Overall Study
    CTLA-4 Ig   Placebo
STARTED   77   35 
COMPLETED   73   30 
NOT COMPLETED   4   5 
Death                1                0 
Withdrawal by Subject                2                2 
Lost to Follow-up                0                2 
Pregnancy                1                0 
Travel issues                0                1 



  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.
No text entered.

Reporting Groups
  Description
CTLA-4 Ig

Intravenous infusions of CTLA-4 Ig

CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses

Placebo

Intravenous infusions of placebo

Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses

Total Total of all reporting groups

Baseline Measures
   CTLA-4 Ig   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 77   35   112 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.9  (6.9)   13.7  (5.3)   13.9  (6.4) 
Gender 
[Units: Participants]
     
Female   36   10   46 
Male   41   25   66 


  Outcome Measures

1.  Primary:   Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit   [ Time Frame: 2 years of follow up ]


  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
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  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: Carla Greenbaum
Organization: Benaroya Research Institute
e-mail: cjgreen@benaroyaresearch.org


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00505375     History of Changes
Other Study ID Numbers: CTLA (IND)
Study First Received: July 20, 2007
Results First Received: May 12, 2016
Last Updated: July 7, 2016
Health Authority: United States: Food and Drug Administration