NCT01030861

Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"

AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 8 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy and safety in previous studies; other studies are currently in progress. The results of previous studies indicate that teplizumab reduces the loss of insulin production during the first year after diagnosis in individuals with type 1 diabetes. The purpose of this study is to determine if teplizumab can interdict the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.

Detailed description

The study plans to enroll approximately 71 subjects between the ages of 8-45 years, over 2-3 years. The study is projected to last between 4-6 years, depending upon rate of enrollment and number of subjects who develop diabetes. The main study objective is to determine whether intervention with teplizumab will prevent or delay the development of type 1 diabetes in high risk autoantibody positive non-diabetic relatives of individuals with T1D. Secondary outcomes are to include analyses of C-peptide and other measures from Oral Glucose Tolerance Testing (OGTT), safety, tolerability, and other mechanistic outcomes will be assessed during the study.

Conditions

• Autoantibody Positive
• Non-diabetic Relatives at Risk for Type 1 Diabetes
• High Risk
• Impaired Glucose Tolerance

Interventions

Type	Name	Description
DRUG	Teplizumab	intravenous infusions
DRUG	Placebo infusion	Placebo for Teplizumab

Timeline

• Start date: 2010-08-01
• Primary completion: 2018-11-01
• Completion: 2019-06-01
• First posted: 2009-12-14
• Last updated: 2020-08-05
• Results posted: 2020-08-05

Locations

19 sites across 3 countries: United States, Canada, Germany