Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00378508 |
Recruitment Status :
Completed
First Posted : September 20, 2006
Results First Posted : October 31, 2012
Last Update Posted : August 2, 2016
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Condition or disease | Intervention/treatment | Phase |
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Type 1 Diabetes Mellitus | Drug: mAb hOKT3gamma1(Ala-Ala), Teplizumab Drug: Placebo Arm | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
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Drug: mAb hOKT3gamma1(Ala-Ala), Teplizumab
This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.
Other Name: mAb hOKT3gamma1(Ala-Ala), MGA031, Teplizumab |
Placebo Comparator: 2
Normal saline infusion
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Drug: Placebo Arm |
- C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months [ Time Frame: At month 12 post-treatment ]
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.
- C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline [ Time Frame: At Baseline (before treatment) ]
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.
- Hemoglobin A1c [ Time Frame: At 12 months post-treatment ]
- Average Insulin Use Over 12 Months [ Time Frame: After 12 months post-treatment ]
- Baseline Insulin Use [ Time Frame: At baseline (before treatment) ]
- Baseline Hemoglobin A1c [ Time Frame: At baseline (before treatment) ]

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Ages Eligible for Study: | 8 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 8 - 30,
- duration of diabetes 4 - 12 months,
- weight greater than 27.5 kg,
- stimulated C-peptide >= 0.2 pmol/ml
Exclusion Criteria:
- asthma,
- history of hepatitis C, hepatitis B, HIV

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378508
United States, California | |
University of California at San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
Barbara Davis Diabetes Center | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06520 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia (CHOP) | |
Philadelphia, Pennsylvania, United States, 10194 |
Principal Investigator: | Kevan C Herold | Yale University | |
Principal Investigator: | Jeffrey A Bluestone, PhD | University of California at San Francisco |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT00378508 |
Other Study ID Numbers: |
Delay-Study 5 R01DK057846 ( U.S. NIH Grant/Contract ) |
First Posted: | September 20, 2006 Key Record Dates |
Results First Posted: | October 31, 2012 |
Last Update Posted: | August 2, 2016 |
Last Verified: | July 2016 |
immune therapy autoimmunity insulin secretion diabetes mellitus |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |