Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
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Purpose
This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: mAb hOKT3gamma1(Ala-Ala), Teplizumab Drug: Placebo Arm |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes |
- 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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Average Insulin Use Over 12 Months [ Time Frame: After 12 months post-treatment ] [ Designated as safety issue: No ]
- Baseline Insulin Use [ Time Frame: At baseline (before treatment) ] [ Designated as safety issue: No ]
- Baseline Hemoglobin A1c [ Time Frame: At baseline (before treatment) ] [ Designated as safety issue: No ]
| Enrollment: | 63 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
Drug: Placebo Arm |
Detailed Description:
The study design is a double blind placebo controlled trial that will enroll subjects between the ages of 8 - 30 who have had the diagnosis of Type 1 diabetes made 4 - 12 months prior to enrollment. A single 14 course of treatment with mAb hOKT3gamma1(Ala-Ala), Teplizumab will be given. The primary endpoint is the C-peptide response to a mixed meal at 12 months. A total of 60 subjects will be enrolled (30 in the drug treatment and 30 in the placebo groups) at 4 study sites: Yale University,the University of California at San Francisco, Children's Hospital of Philadelphia, and the Barbara Davis Diabetes Center.
Eligibility| Ages Eligible for Study: | 8 Years to 30 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
Publications:
| Responsible Party: | Kevan Herold, Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00378508 History of Changes |
| Other Study ID Numbers: | Delay-Study 5, R01DK57846 |
| Study First Received: | September 18, 2006 |
| Results First Received: | September 4, 2012 |
| Last Updated: | October 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Yale University:
|
immune therapy autoimmunity insulin secretion diabetes mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013