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CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01773707
Recruitment Status : Recruiting
First Posted : January 23, 2013
Last Update Posted : May 14, 2019
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:

The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial.

All subjects will receive close monitoring for development of AGT or T1DM. Subjects will receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM.

The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM.

Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic outcomes.

Condition or disease Intervention/treatment Phase
Abnormal Glucose Tolerance Type 1 Diabetes Drug: CTLA4-Ig (Abatacept) Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1 Diabetes
Actual Study Start Date : March 2013
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Abatacept

Arm Intervention/treatment
Experimental: abatacept IV infusion
CTLA4-Ig (Abatacept) will be administered as 14 (30 minute) infusions over one year (3 infusions every other week the first month; monthly for the following 11 months)
Drug: CTLA4-Ig (Abatacept)
Given as 30 minute IV infusion
Other Name: Abatacept

Placebo Comparator: Placebo
The placebo arm will receive 14 (30 minute) IV infusions (containing saline) given 3 times (every other week) the first month and monthly for the following 11 months.
Drug: Placebo
Saline given as 30 minute IV infusion

Primary Outcome Measures :
  1. Change from Normal Glucose Tolerance to Abnormal Glucose Tolerance [ Time Frame: every six months for 5-6 years ]

    Measured by Oral Glucose Tolerance Test (OGTT):

    Abnormal Glucose Tolerance is primary endpoint and defined as:

    1. Fasting plasma glucose ≥ 110 mg/dL (6.1 mmol/L) and < 126 mg/dL (7 mmol/L), or
    2. 2 hour plasma glucose ≥ 140 mg/dL (7.8 mmol/L) and < 200 (11.1 mmol/L), or
    3. 30, 60, 90 minute plasma glucose during OGTT ≥ 200 mg/dL (11.1 mmol/L)

Secondary Outcome Measures :
  1. Change in C-peptide response to Oral Glucose Tolerance Test (OGTT) [ Time Frame: Every six months for 5-6 years ]
    To Determine whether treatment with Abatacept is superior to placebo with respect to C-peptide response to oral glucose tolerance

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participant in TrialNet Natural History/Pathway to Prevention Study and thus, a relative of a proband with T1DM.
  • Between the ages of 1-45 years at the time of enrollment in TN01 and age ≥ 6 at time of randomization in this trial.
  • Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is <18 years of age.
  • Normal glucose tolerance by OGTT confirmed within 7 weeks (no more than 52 days) of baseline (visit 0). If previous abnormal glucose tolerance, has had two consecutive OGTTs with normal glucose tolerance.

    1. Fasting plasma glucose < 110 mg/dL (6.1 mmol/L), and
    2. 2 hour plasma glucose <140 mg/dL (7.8 mmol/L), and
    3. 30, 60, or 90 minute value on OGTT< 200mg/dL (11.1 mmol/L)
  • At least two diabetes-related autoantibodies confirmed to be present on two occasions, not including mIAA. Confirmation of 2 positive autoantibodies must occur within the six months prior to randomization, but the confirmation does not have to involve the same 2 autoantibodies.
  • Weight ≥ 20 kg at Baseline Visit.
  • If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to each infusion.
  • At least three months from date of last live immunization.
  • Willing to forgo live vaccines while receiving treatment on study and for three months following last study drug administration.

Exclusion Criteria:

  • Abnormal Glucose Tolerance or Diabetes

    1. Fasting plasma glucose ≥ 110 mg/dL (6.1 mmol/L), or
    2. 2 hour plasma glucose ≥ 140 mg/dL (7.8 mmol/L), or
    3. 30, 60, 90 minute plasma glucose during OGTT ≥ 200 mg/dL (11.1 mmol/L)
  • Insulin autoantibodies (mIAA).
  • Are immunodeficient or have clinically significant chronic lymphopenia.
  • Have an active infection at time of randomization.
  • Have a positive PPD test result or history of previously treated TB, or positive interferon-gamma release assay (IGRA) test.
  • Be currently pregnant or lactating, or anticipate getting pregnant within 3 months of the last study drug administration.
  • Use of medications known to influence glucose tolerance.
  • Require use of other immunosuppressive agents.
  • Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection.
  • Have serological evidence of current CMV infection.
  • Have evidence of active EBV infection.
  • Have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. These include pre-existing cardiac disease, COPD, neurological, or blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia).

Information from the National Library of Medicine

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 identifier (NCT number): NCT01773707

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Contact: Lisa E Rafkin, MS 305-243-6146
Contact: Ryan O'Donnell, MS ryan.o'

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United States, California
University of California - San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: David Ng    415-514-3730   
Contact: Kathy Breen, RN, CDE    (415) 502-8640   
Principal Investigator: Stephen Gitelman, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305-5208
Contact: Trudy Esrey, RD    650-498-4450   
Principal Investigator: Darrell Wilson, MD         
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado Not yet recruiting
Denver, Colorado, United States, 80262
Contact: Laurie Weiner, RN    303-315-0266   
Principal Investigator: Peter Gottlieb, MD         
United States, Connecticut
Yale Medical School Not yet recruiting
New Haven, Connecticut, United States
Contact: Laurie Feldman, RN    203-737-2760   
Principal Investigator: Kevan Herold, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610-
Contact: Roberta Cook, RN    352-294-5759   
Principal Investigator: Desmond A. Schatz, MD         
University of Miami School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Della Matheson, RN    305-243-3781   
Principal Investigator: Jennifer Marks, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Gail Gannon    773-702-3853   
Principal Investigator: Louis Philipson, MD         
United States, Indiana
Indiana University-Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maria Nicholson   
Principal Investigator: Linda DiMeglio, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 57931
Contact: Jennifer Smith, RN    612-624-6682   
Principal Investigator: Antoinette Moran, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States
Contact: Ellen Greenberg, MPH    212-851-5425   
Principal Investigator: Robin Golan, MD         
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Karen Riley, RN    412-692-5210   
Principal Investigator: Dorothy Becker, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Karen Riley, RN    412-692-5210   
Principal Investigator: Dorothy Becker, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States
Contact: Faith Brendle    615-936-8638   
Principal Investigator: William Russell, MD         
United States, Texas
University of Texas Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390-8858
Contact: Philip Raskin, M.D.    214-648-4844   
Contact: Lourdes Pruneda, RN    (214) 648-4717   
Principal Investigator: Philip Raskin, M.D.         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Sandra Pena    832-822-3380   
Principal Investigator: Maria Redondo, MD         
United States, Washington
Benaroya Research Institute at Virginia Mason Recruiting
Seattle, Washington, United States, 98101
Contact: Marli McCulloch-Olson    800-888-4187   
Principal Investigator: Carla Greenbaum, MD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, MSG-1X8
Contact: Lesley Eisel, RN    416-813-8159   
Principal Investigator: Diane Wherrett, MD         
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
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Study Chair: Carla J Greenbaum, MD Type 1 Diabetes TrialNet

Additional Information:
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT01773707     History of Changes
Other Study ID Numbers: Abatacept (IND)
UC4DK106993 ( U.S. NIH Grant/Contract )
UC4DK117009 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
prevention of type 1 diabetes
prevention of abnormal glucose tolerance
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents