Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

This study has been terminated.
(Changes to study personnel.)
Sponsor:
Information provided by (Responsible Party):
James Balow, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00837759
First received: February 4, 2009
Last updated: December 31, 2012
Last verified: December 2012
Results First Received: March 24, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes Mellitus Type 1
Autoimmune Diabetes
Interventions: Drug: Insulin
Drug: Lansoprazole
Drug: Sitagliptin
Biological: Diamyd
Drug: GAD65 (Diamyd)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
T1D Group Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.

Participant Flow:   Overall Study
    T1D Group  
STARTED     7  
COMPLETED     3  
NOT COMPLETED     4  
Protocol Violation                 3  
Lost to Follow-up                 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
T1D Group Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.

Baseline Measures
    T1D Group  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     6  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  21.9  ± 3.2  
Gender  
[units: participants]
 
Female     2  
Male     5  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     7  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in C-peptide   [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]

2.  Secondary:   Glycemia Control (Change in HbA1c Level)   [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]

3.  Secondary:   Change in Insulin Dose   [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]

4.  Secondary:   Change in Anti-GAD Autoantibody Titers   [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]

5.  Secondary:   Change in Anti-IA2 Titer   [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]

6.  Secondary:   Change in ZnT8 Autoantibody Titer   [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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Results Point of Contact:  
Name/Title: Dr. Rana Malek
Organization: NIDDK, National Institutes of Health
phone: 3015945288
e-mail: malekr@mail.nih.gov


Publications:

Responsible Party: James Balow, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00837759     History of Changes
Other Study ID Numbers: 090056, 09-DK-0056, 09-DK-0056
Study First Received: February 4, 2009
Results First Received: March 24, 2012
Last Updated: December 31, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration