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Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01781975
Recruitment Status : Active, not recruiting
First Posted : February 1, 2013
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Stephen E. Gitelman, University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type I
Diabetes Mellitus, Insulin-Dependent, 1
Type 1 Diabetes Mellitus
Insulin-Dependent Diabetes Mellitus 1
IDDM
Interventions: Drug: Imatinib Mesylate
Drug: Placebo (For imatinib mesylate)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: March 2013 to May 2016 at 9 clinical sites (8 US, 1 Australia)

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
Imatinib Mesylate

400 mg imatinib given once daily basis.

Imatinib Mesylate

Placebo

Placebo given once daily basis.

Placebo (For imatinib mesylate)


Participant Flow:   Overall Study
    Imatinib Mesylate   Placebo
STARTED   45   22 
Treatment Period   44   22 
Follow-Up Period   43   21 
COMPLETED   43   21 
NOT COMPLETED   2   1 
Death                1                0 
Withdrawal by Subject                1                1 



  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
Imatinib Mesylate

400 mg imatinib given once daily basis.

Imatinib Mesylate

Placebo

Placebo given once daily basis.

Placebo (For imatinib mesylate)

Total Total of all reporting groups

Baseline Measures
   Imatinib Mesylate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   22   67 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      45 100.0%      22 100.0%      67 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.2  (7.2)   26.2  (6.6)   27  (7.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  40.0%      12  54.5%      30  44.8% 
Male      27  60.0%      10  45.5%      37  55.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   4.4%      3  13.6%      5   7.5% 
Not Hispanic or Latino      43  95.6%      19  86.4%      62  92.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   2.2%      0   0.0%      1   1.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      44  97.8%      21  95.5%      65  97.0% 
More than one race      0   0.0%      1   4.5%      1   1.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   36   18   54 
Australia   9   4   13 
Number of Autoantibodies Positive 
[Units: Participants]
Count of Participants
     
    8  17.8%      4  18.2%      12  17.9% 
    8  17.8%      4  18.2%      12  17.9% 
    12  26.7%      1   4.5%      13  19.4% 
    8  17.8%      6  27.3%      14  20.9% 
    9  20.0%      7  31.8%      16  23.9% 


  Outcome Measures

1.  Primary:   Area Under the Stimulated C-peptide Curve (AUC) Mean Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 1 Year Visit   [ Time Frame: Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose ]

2.  Secondary:   Area Under the Stimulated C-peptide Curve (AUC) Mean Over 4 Hours at 24 Months   [ Time Frame: Visit 13 (Week 104) ]
Results not yet reported.   Anticipated Reporting Date:   05/2019  

3.  Secondary:   Change in HbA1c Levels Over Time   [ Time Frame: Visit 9 (Week 52) and Visit 13 (Week 104) ]
Results not yet reported.   Anticipated Reporting Date:   05/2019  

4.  Secondary:   Change in Insulin Dose (Units/kg) Over Time   [ Time Frame: Visit 9 (Week 52) and Visit 13 (Week 104) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Number of Severe Hypoglycemic Events   [ Time Frame: Visit 0 (Week 0), Visit 9 (Week 52), and Visit 13 (Week 52) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Number and Severity of Adverse Events   [ Time Frame: Adverse Events will be assessed at Visit 0 (week 0), Visit 1 (Week 2), Visit 2 (Week 4), and every month thereafter. ]
Results not yet reported.   Anticipated Reporting Date:   05/2019  


  Serious Adverse Events


  Other Adverse Events


  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
FDA did not approve for hold on enrollment of pediatric population to be lifted; only adult population was recruited.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nichole Reed
Organization: University of South Florida
phone: 813-396-9219
e-mail: Nichole.Reed@epi.usf.edu



Responsible Party: Stephen E. Gitelman, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01781975     History of Changes
Other Study ID Numbers: 17-2013-6
First Submitted: January 17, 2013
First Posted: February 1, 2013
Results First Submitted: May 25, 2018
Results First Posted: August 8, 2018
Last Update Posted: August 8, 2018