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Autoantibody PositivePhase 2NCT01030861

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

A Phase 2 study testing Teplizumab in people with Autoantibody Positive and Non-diabetic Relatives at Risk for Type 1 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 19 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 45 years
What is being tested?
Teplizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
19 sitesin 3 countries
Study dates
Aug 2010to Jun 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Be currently pregnant or lactating
  • Prior treatment with study drug
  • Prior treatment with other monoclonal antibody in past one year

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

United States17 sites

  • University of Texas

    Dallas, Texas, 75390-9072

  • Barbara Davis Center for Childhood Diabetes/ University of Colorado

    Denver, Colorado, 80045

  • University of Florida

    Gainesville, Florida, 32610

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • Columbia University

    New York, New York, 10032

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15201

  • University of California in San Francisco

    San Francisco, California, 94143

  • University of California-San Francisco

    San Francisco, California, 94143

  • Benaroya Research Institute

    Seattle, Washington, 982101

  • Stanford University

    Stanford, California, 94305

  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, MSG-1X8

Other trials in Canada

Germany1 site

  • Forschergruppe Diabetes

    Munich

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Teplizumab, Placebo infusion
Keywords
type 1 diabetes, pre-diabetic, autoantibody positive, at risk for type 1 diabetes, glucose intolerance, relatives of people with type 1 diabetes
Medical subject headings
Glucose Intolerance, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeplizumabDrug

    intravenous infusions

  • Placebo infusionDrug

    Placebo for Teplizumab

Study groups in NCT01030861
Study groupRoleWhat they receive
teplizumabActive comparatorIntravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
Receives: Drug: Teplizumab
Placebo infusionPlacebo comparatorIntravenous 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.
Receives: Drug: Placebo infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of New Diabetes Per Year

    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.

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

Secondary outcomes (1)

  1. Number of Participants With Adverse Events

    Adverse events categorized and graded via CTCAE.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2009 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2018
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01030861
Sponsor's protocol ID
TrialNet - tep (IND)
Other IDs
UC4DK106993
Status last verified
Jul 2020
First submitted
11 Dec 2009
Last updated
5 Aug 2020
Data monitoring committee
Yes
Individual data sharing
Yes: 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

Publications

  • Ajmal N, Bogart MC, Khan P, Max-Harry IM, Healy AM, Nunemaker CS. Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. J Diabetes Res. 2024 Dec 20;2024:5151171. doi: 10.1155/jdr/5151171. eCollection 2024.

    PubMed 39735417

  • Lledo-Delgado A, Preston-Hurlburt P, Currie S, Clark P, Linsley PS, Long SA, Liu C, Koroleva G, Martins AJ, Tsang JS, Herold KC. Teplizumab induces persistent changes in the antigen-specific repertoire in individuals at risk for type 1 diabetes. J Clin Invest. 2024 Aug 13;134(18):e177492. doi: 10.1172/JCI177492.

    PubMed 39137044

  • Novograd J, Frishman WH. Teplizumab Therapy to Delay the Onset of Type 1 Diabetes. Cardiol Rev. 2024 Nov-Dec 01;32(6):572-576. doi: 10.1097/CRD.0000000000000563. Epub 2023 May 9.

    PubMed 37158990

  • Leung SS, Borg DJ, McCarthy DA, Boursalian TE, Cracraft J, Zhuang A, Fotheringham AK, Flemming N, Watkins T, Miles JJ, Groop PH, Scheijen JL, Schalkwijk CG, Steptoe RJ, Radford KJ, Knip M, Forbes JM. Soluble RAGE Prevents Type 1 Diabetes Expanding Functional Regulatory T Cells. Diabetes. 2022 Sep 1;71(9):1994-2008. doi: 10.2337/db22-0177.

    PubMed 35713929

  • Herold KC, Bundy BN, Long SA, Bluestone JA, DiMeglio LA, Dufort MJ, Gitelman SE, Gottlieb PA, Krischer JP, Linsley PS, Marks JB, Moore W, Moran A, Rodriguez H, Russell WE, Schatz D, Skyler JS, Tsalikian E, Wherrett DK, Ziegler AG, Greenbaum CJ; Type 1 Diabetes TrialNet Study Group. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med. 2019 Aug 15;381(7):603-613. doi: 10.1056/NEJMoa1902226. Epub 2019 Jun 9.

    PubMed 31180194

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Teplizumab in people with Autoantibody Positive and Non-diabetic Relatives at Risk for Type 1 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 19 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of New Diabetes Per Year (time frame: During follow-up, median 745 days, range 74 to 2683). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01030861, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.

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