Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
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|ClinicalTrials.gov Identifier: NCT01030861|
Recruitment Status : Completed
First Posted : December 14, 2009
Results First Posted : August 5, 2020
Last Update Posted : August 5, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Autoantibody Positive Non-diabetic Relatives at Risk for Type 1 Diabetes High Risk Impaired Glucose Tolerance||Drug: Teplizumab Drug: Placebo infusion||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus|
|Actual Study Start Date :||August 2010|
|Actual Primary Completion Date :||November 2018|
|Actual Study Completion Date :||June 2019|
Active Comparator: teplizumab
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
Placebo Comparator: Placebo infusion
Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.
Drug: Placebo infusion
Placebo for Teplizumab
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||8 Years to 45 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030861
|Study Chair:||Carla J Greenbaum, MD||Type 1 Diabetes TrialNet|
Documents provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Other Study ID Numbers:||
TrialNet - tep (IND)
UC4DK106993 ( U.S. NIH Grant/Contract )
|First Posted:||December 14, 2009 Key Record Dates|
|Results First Posted:||August 5, 2020|
|Last Update Posted:||August 5, 2020|
|Last Verified:||July 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Data are available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository: https://repository.niddk.nih.gov/studies/tn10-anti-cd3-prevention/?query=trialnet%20Teplizumab|
type 1 diabetes
at risk for type 1 diabetes
relatives of people with type 1 diabetes
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases