Overview

This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Treatments mab hokt3gamma1(ala-ala), teplizumab, placebo arm
Phase phase 2
Sponsor Yale University
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date September 2006
End date August 2011
Trial size 63 participants
Trial identifier NCT00378508, Delay-Study 5, R01DK57846

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(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.
mab hokt3gamma1(ala-ala), teplizumab mAb hOKT3gamma1(Ala-Ala), MGA031, 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.
(Placebo Comparator)
Normal saline infusion
placebo arm

Primary Outcomes

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
C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline
time frame: At Baseline (before treatment)

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants from 8 years up to 30 years old.

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

Additional Information

Official title Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes
Principal investigator Kevan C Herold
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Yale University.