Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects

This study has been completed.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
National Center for Research Resources (NCRR)
American Diabetes Association
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00529399
First received: September 12, 2007
Last updated: October 15, 2016
Last verified: October 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: GAD-Alum
Drug: GAD-Alum and Aluminum hydroxide
Drug: Aluminum hydroxide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The original recruitment goal was to enroll 126 subjects. However, additional eligible subjects were identified during the screening process and 145 subjects were enrolled in the study.

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
GAD-alum

3 injections of Glutamic Acid Decarboxylase (GAD)-Alum vaccine

GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.

GAD-alum Plus Alum

2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone

GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.

Alum Alone

3 injections of Aluminum hydroxide alone

Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.


Participant Flow:   Overall Study
    GAD-alum   GAD-alum Plus Alum   Alum Alone
STARTED   48   49   48 
COMPLETED   46   48   46 
NOT COMPLETED   2   1   2 
Lost to Follow-up                1                0                1 
Withdrawal by Subject                1                0                1 
Non-compliant                0                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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
GAD-alum

3 injections of GAD-Alum vaccine

GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.

GAD-alum Plus Alum

2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone

GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.

Alum Alone

3 injections of Aluminum hydroxide alone

Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.

Total Total of all reporting groups

Baseline Measures
   GAD-alum   GAD-alum Plus Alum   Alum Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   49   48   145 
Age 
[Units: Years]
Mean (Standard Deviation)
 17.8  (10.3)   14.8  (8.7)   16.6  (9.2)   16.4  (9.5) 
Gender 
[Units: Participants]
       
Female   14   31   19   64 
Male   34   18   29   81 


  Outcome Measures

1.  Primary:   The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit   [ Time Frame: Based on mixed meal tolerance test (MMTT) conducted at the one year visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: NCT00529399     History of Changes
Other Study ID Numbers: GAD65 (IND)
Study First Received: September 12, 2007
Results First Received: May 12, 2016
Last Updated: October 15, 2016
Health Authority: United States: Food and Drug Administration