Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00837759
Recruitment Status : Terminated (Changes to study personnel.)
First Posted : February 5, 2009
Results First Posted : October 24, 2012
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
James Balow, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes Mellitus Type 1
Autoimmune Diabetes
Interventions Drug: Insulin
Drug: Lansoprazole
Drug: Sitagliptin
Biological: Diamyd
Drug: GAD65 (Diamyd)
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title T1D Group
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 7
Completed 3
Not Completed 4
Reason Not Completed
Protocol Violation             3
Lost to Follow-up             1
Arm/Group Title T1D Group
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
1
  14.3%
Between 18 and 65 years
6
  85.7%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
21.9  (3.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
2
  28.6%
Male
5
  71.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
7
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Change in C-peptide
Hide Description [Not Specified]
Time Frame 6 months following the protocol subject's randomization/treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 subjects completed study
Arm/Group Title T1D Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.51  (0.53)
2.Secondary Outcome
Title Glycemia Control (Change in HbA1c Level)
Hide Description [Not Specified]
Time Frame 6 months following the protocol subject's randomization/treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 subjects completed study
Arm/Group Title T1D Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: Percentage
-1.17  (0.45)
3.Secondary Outcome
Title Change in Insulin Dose
Hide Description [Not Specified]
Time Frame 6 months following the protocol subject's randomization/treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T1D Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: U/kg/day
0.02  (0.32)
4.Secondary Outcome
Title Change in Anti-GAD Autoantibody Titers
Hide Description [Not Specified]
Time Frame 6 months following the protocol subject's randomization/treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T1D Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3
Mean (Standard Error)
Unit of Measure: Titers
119278  (174649)
5.Secondary Outcome
Title Change in Anti-IA2 Titer
Hide Description [Not Specified]
Time Frame 6 months following the protocol subject's randomization/treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T1D Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3
Mean (Standard Error)
Unit of Measure: Titers
-29212  (49956)
6.Secondary Outcome
Title Change in ZnT8 Autoantibody Titer
Hide Description [Not Specified]
Time Frame 6 months following the protocol subject's randomization/treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T1D Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3
Mean (Standard Error)
Unit of Measure: Titers
-0.11  (0.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T1D Group
Hide Arm/Group Description 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.
All-Cause Mortality
T1D Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
T1D Group
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T1D Group
Affected / at Risk (%) # Events
Total   3/7 (42.86%)    
General disorders   
Rhinitis  1/3 (33.33%)  1
Eczema  1/3 (33.33%)  2
Warts  1/3 (33.33%)  2
Thrombocytopenia  1/3 (33.33%)  1
Gastroenteritis  1/3 (33.33%)  2
Anemia  1/3 (33.33%)  1
Metabolism and nutrition disorders   
Hypoglycemic events [1]  3/3 (100.00%)  104
[1]
According to the protocol, hypoglycemia adverse events are described as follows: Mild= BG < 65 mg/dL Moderate = BG < 54 mg/dL & symptomatic Severe = patient required assistance to obtain treatment for the event.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rana Malek
Organization: NIDDK, National Institutes of Health
Phone: 3015945288
EMail: malekr@mail.nih.gov
Layout table for additonal information
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 ( Other Identifier: National Institutes of Health Clinical Center )
09-DK-0056 ( Other Identifier: NIHCC )
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: March 24, 2012
Results First Posted: October 24, 2012
Last Update Posted: January 3, 2013