| Trial ID: | L5797 |
| Source ID: | NCT01781975
|
| Associated Drug: |
Imatinib Mesylate
|
| Title: |
Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01781975/results
|
| 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)
|
| Outcome Measures: |
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, The primary outcome of each participant is the area under the stimulated c-peptide curve (AUC) mean based on data collected at time 0 to 2 hours of a 4-hour mixed meal tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30, 60, 90, and 120 minutes. The term "AUC mean" comes from the mean value theorem in calculus. It is the value on the scale of the y-axis that is equal to the AUC divided by the range on the x-axis (in this case 120 minutes)., Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose | Secondary: Area Under the Stimulated C-peptide Curve (AUC) Mean Over 4 Hours at 24 Months, Area under the MMTT-stimulated peak, 4 hour C-peptide AUC mean at week 104. The units are reported as nano-moles/Liter because this is AUC mean (the AUC is divided by the time internal so that the units return to the c-peptide units of measure)., Visit 13 (Week 104)|Change in HbA1c Levels Over Time, Change in HbA1c levels from Week 52 to Week 104, Visit 9 (Week 52) and Visit 13 (Week 104)|Change in Insulin Dose (Units/kg) Over Time, Assess insulin use in units per kilogram body weight per day at weeks 52 and 104., Visit 9 (Week 52) and Visit 13 (Week 104)|Number of Severe Hypoglycemic Events, Major hypoglycemic events occurring from randomization at weeks 0, 52 and 104., Visit 0 (Week 0), Visit 9 (Week 52), and Visit 13 (Week 104)|Number of Adverse Events, Number of adverse events that were reported throughout the study., Adverse Events will be assessed at Visit 0 (week 0), Visit 1 (Week 2), Visit 2 (Week 4), and every month thereafter.
|
| Sponsor/Collaborators: |
Sponsor: University of California, San Francisco | Collaborators: Juvenile Diabetes Research Foundation
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| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
67
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
|
| Completion Date: |
2018-05
|
| Results First Posted: |
2018-08-08
|
| Last Update Posted: |
2020-02-11
|
| Locations: |
University of California-San Francisco, San Francisco, California, 94143, United States|Barbara Davis Center, Aurora, Colorado, 80045, United States|Emory University, Atlanta, Georgia, 30322, United States|Indiana University, Indianapolis, Indiana, 46202, United States|University of Iowa, Iowa City, Iowa, 52242, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|University of Texas Southwestern, Dallas, Texas, 75390, United States|Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, 3050, Australia
|
| URL: |
https://clinicaltrials.gov/show/NCT01781975
|
