Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Kevan Herold, Yale University
ClinicalTrials.gov Identifier:
NCT00378508
First received: September 18, 2006
Last updated: October 31, 2012
Last verified: October 2012

September 18, 2006
October 31, 2012
September 2006
August 2011   (final data collection date for primary outcome measure)
  • 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.

C-peptide response to a mixed meal tolerance test
Complete list of historical versions of study NCT00378508 on ClinicalTrials.gov Archive Site
  • 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 ]
  • hemoglobin A1c
  • insulin usage
Not Provided
Not Provided
 
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • 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
  • Drug: Placebo Arm
  • 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.
    Intervention: Drug: mAb hOKT3gamma1(Ala-Ala), Teplizumab
  • Placebo Comparator: 2
    Normal saline infusion
    Intervention: Drug: Placebo Arm

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
63
August 2013
August 2011   (final data collection date for primary outcome measure)

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
Both
8 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00378508
Delay-Study 5, R01DK57846
Yes
Kevan Herold, Yale University
Yale University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Juvenile Diabetes Research Foundation
Principal Investigator: Kevan C Herold Yale University
Principal Investigator: Jeffrey A Bluestone, PhD University of California at San Francisco
Yale University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP