| Trial ID: | L4627 |
| Source ID: | NCT00378508
|
| Associated Drug: |
Mab Hokt3gamma1(Ala-Ala), Teplizumab
|
| Title: |
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00378508/results
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: mAb hOKT3gamma1(Ala-Ala), Teplizumab|DRUG: Placebo Arm
|
| Outcome Measures: |
Primary: C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months, C-peptide secretory response was calculated as ln\[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1\] For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline., At month 12 post-treatment|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline, C-peptide secretory response was calculated as ln\[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1\] For presentation, the C-peptide data were converted to the AUC as pmol/ml. This baseline data was used to adjust for the C-peptide AUC primary endpoint measure at 12 months., At Baseline (before treatment) | Secondary: Hemoglobin A1c, At 12 months post-treatment|Average Insulin Use Over 12 Months, After 12 months post-treatment|Baseline Insulin Use, At baseline (before treatment)|Baseline Hemoglobin A1c, At baseline (before treatment)
|
| Sponsor/Collaborators: |
Sponsor: Yale University | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
63
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2013-08
|
| Results First Posted: |
2012-10-31
|
| Last Update Posted: |
2021-08-13
|
| Locations: |
University of California at San Francisco, San Francisco, California, 94143, United States|Barbara Davis Diabetes Center, Aurora, Colorado, 80045, United States|Yale University, New Haven, Connecticut, 06520, United States|Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, 10194, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00378508
|
