Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

Yale University

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Placebo Arm; Drug: mAb hOKT3gamma1(Ala-Ala), Teplizumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00378508

Delay-Study 5

R01DK057846 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 8 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Drug: mAb hOKT3gamma1(Ala-Ala), Teplizumab

2

Placebo Comparator group

Description:

Normal saline infusion

Treatment:

Drug: Placebo Arm