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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
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE September 18, 2006
First Posted Date  ICMJE September 20, 2006
Results First Submitted Date  ICMJE September 4, 2012
Results First Posted Date  ICMJE October 31, 2012
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE September 2006
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2006)
C-peptide response to a mixed meal tolerance test
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2006)
  • Hemoglobin A1c
  • insulin usage
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
Official Title  ICMJE Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2012)
63
Original Enrollment  ICMJE
 (submitted: September 18, 2006)
60
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00378508
Other Study ID Numbers  ICMJE Delay-Study 5
R01DK057846 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Juvenile Diabetes Research Foundation
Investigators  ICMJE
Principal Investigator: Kevan C Herold Yale University
Principal Investigator: Jeffrey A Bluestone, PhD University of California at San Francisco
PRS Account Yale University
Verification Date July 2016

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