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NCT Number: NCT01030861

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

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.

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Key information

Conditions

Autoantibody Positive Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders High Risk Hyperglycemia Immune System Diseases Impaired Glucose Tolerance Metabolic Diseases Non-diabetic Relatives at Risk for Type 1 Diabetes Nutritional and Metabolic Diseases

Age range

8 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between ages of 8-45 years
  • Have a relative with type 1 diabetes
  • If first degree relative must be 8-45 years old (brother, sister, parent, offspring)
  • If second degree relative must be between 8-20 years old (niece, nephew, aunt, uncle, grandchild, cousin)
  • Abnormal glucose tolerance by OGTT confirmed with 7 weeks of baseline visit [fasting blood glucose greater than 110mg/dL or and less than 126 mg/dL OR 2 hour glucose greater or equal to 140 mg/dL and less than 200 mg/dL OR 30, 60, or 90 minute value on OGTT greater than or equal to 200 mg/dL]
  • Presence of at least two confirmed diabetes autoantibodies

Exclusion criteria

  • type 1 diabetes previously diagnosed or detected at screening [fasting glucose greater or equal to 126 mg/dL or 2 hour glucose greater or equal to 200 mg/dL]
  • abnormalities in blood counts, liver enzymes, international normalised ratio (INR),
  • positive purified protein derivative (PPD) test
  • vaccination with live virus within 6 weeks of randomization
  • evidence of acute infection based on laboratory testing or clinical evidence
  • serological evidence of past current or past HIV , hepatitis B, or hepatitis C infection
  • Be currently pregnant or lactating
  • Prior treatment with study drug
  • Prior treatment with other monoclonal antibody in past one year

Treatment and study plan

Teplizumab

Drug

intravenous infusions

placebo infusion

Drug

Placebo for Teplizumab

Primary outcomes

  1. Rate of New Diabetes Per Year

    Time frame: During follow-up, median 745 days, range 74 to 2683

    Rate at which criteria are met for diabetes onset as defined by the American Diabetes Association (ADA) based on glucose testing or the presence of unequivocal hyperglycemia with acute metabolic decompensation.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Baseline Visit to Diagnosis of Type 1 Diabetes median 745 days, range 74 to 2683

    Adverse events categorized and graded via CTCAE.

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • American Diabetes Association
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Juvenile Diabetes Research Foundation
  • National Center for Research Resources (NCRR)
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2018
Study completion
2019
First posted
Dec 14, 2009
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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