Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes - Full Text View

Sponsor:	Yale University
Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Juvenile Diabetes Research Foundation
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00378508

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	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

C-peptide response to a mixed meal tolerance test [ Time Frame: At month 12 post-treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

hemoglobin A1c [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
insulin usage [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator Normal saline infusion	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.

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378508

Contacts

Contact: Kevan C Herold, MD	203-785-6507	kevan.herold@yale.edu
Contact: Stephen Gitelman, MD	4154763748	sgitelma@peds.ucsf.edu

Locations

United States, California
University of California at San Francisco	Recruiting
San Francisco, California, United States, 94143
Contact: Stephen Gitelman, MD 415-476-3748 sgitelma@peds.ucsf.edu
Principal Investigator: Stephen Gitelman, MD
United States, Colorado
Barbara Davis Diabetes Center	Recruiting
Aurora, Colorado, United States, 80045
Contact: Peter A Gottlieb, MD 303-724-6714 peter.gottlieb@ucdenver.edu
Principal Investigator: Peter A Gottlieb, MD
United States, Connecticut
Yale University	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Kevan C Herold, MD 203-785-6507 kevan.herold@yale.edu
Principal Investigator: Kevan C Herold, MD
United States, Pennsylvania
Children's Hospital of Philadelphia (CHOP)	Recruiting
Philadelphia, Pennsylvania, United States, 10194
Contact: Steven Willi, MD 267-426-7037 willi@email.chop.edu
Principal Investigator: Steven Willi, MD

Sponsors and Collaborators

Yale University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Juvenile Diabetes Research Foundation

Investigators

Principal Investigator:	Kevan C Herold	Yale University
Principal Investigator:	Jeffrey A Bluestone, PhD	University of California at San Francisco

More Information

Publications:

Herold KC, Hagopian W, Auger JA, Poumian-Ruiz E, Taylor L, Donaldson D, Gitelman SE, Harlan DM, Xu D, Zivin RA, Bluestone JA. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med. 2002 May 30;346(22):1692-8.

Herold KC, Gitelman SE, Masharani U, Hagopian W, Bisikirska B, Donaldson D, Rother K, Diamond B, Harlan DM, Bluestone JA. A single course of anti-CD3 monoclonal antibody hOKT3gamma1(Ala-Ala) results in improvement in C-peptide responses and clinical parameters for at least 2 years after onset of type 1 diabetes. Diabetes. 2005 Jun;54(6):1763-9.

Responsible Party:	Yale University School of Medicine ( Kevan Herold, MD )
Study ID Numbers:	Delay-Study 5, R01DK57846
Study First Received:	September 18, 2006
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00378508 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Yale University:

immune therapy
autoimmunity
insulin secretion
diabetes mellitus

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010