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Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D

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.
 
ClinicalTrials.gov Identifier: NCT03632759
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Carla Greenbaum, MD, Benaroya Research Institute

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE August 15, 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL. [ Time Frame: 0-to-8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
Official Title  ICMJE Targeting Beta Cell Dysfunction in Longstanding T1D
Brief Summary The purpose of this study is to determine whether 8 weeks of Liraglutide or Golimumab can transiently improve beta cell function in patients with longstanding Type 1 diabetes (T1D) who secrete proinsulin and little/no C-peptide.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
two independent open label, proof of concept studies
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Liraglutide
    Participants will receive subcutaneous (SC) liraglutide for 8 weeks
    Other Name: Victoza
  • Drug: Golimumab
    Participants will receive subcutaneous (SC) golimumab for 8 weeks
    Other Name: SIMPONI
Study Arms  ICMJE
  • Experimental: Liraglutide
    Participants will receive subcutaneous (SC) liraglutide for 8 weeks
    Intervention: Drug: Liraglutide
  • Experimental: Golimumab
    Participants will receive subcutaneous (SC) golimumab for 8 weeks
    Intervention: Drug: Golimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥ 3 years from Type 1 diabetes diagnosis
  2. Males and females 18-50 years of age, inclusive
  3. Peak MMTT stimulated C-peptide <0.017 pmol/mL
  4. Proinsulin levels ≥ 2 pM (either fasting or stimulated)
  5. Females of child-bearing potential must be willing to use effective birth control for 12 weeks
  6. Willing and able to give informed consent for participation
  7. HbA1c ≤ 8.5%

Exclusion Criteria:

  1. Concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of screening MMTT (V-2).
  2. History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies.
  3. Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT or AST> 1.5 x the upper limit of age-determined normal (ULN) .
  4. Females who are pregnant or lactating.
  5. Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment.
  6. History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac and stable thyroid disease.
  7. Current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin).
  8. Any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial.
  9. For Study A (liraglutide)

    1. Any history of pancreatitis or elevated amylase or lipase.
    2. Any personal or family history of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).
    3. Any personal or family history of multiple endocrine neoplasia syndrome type 2.
    4. Hypersensitivity to liraglutide.
    5. Previous treatment with liraglutide.
    6. Known history of clinically significant gastroparesis.
  10. For Study B (golimumab)

    1. Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections.
    2. Any history of demyelinating diseases (such as multiple sclerosis), heart failure, or left ventricular dysfunction.
    3. Serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C.
    4. Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection.
    5. Active infection with EBV, defined by real-time PCR.
    6. Active infection with CMV, defined by real-time PCR.
    7. Any of the following hematologic abnormalities at screening:

      • White blood count <3,000/μL or >14,000/μL
      • Lymphocyte count <500/μL
      • Platelet count <140,000 /μL
      • Hemoglobin <8.5 g/dL
      • Neutrophil count <2,000 cells/μL
    8. Receipt of live vaccine (in the 6 weeks before treatment)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marli McCulloch-Olson 1-800-888-4187 diabetes@benaroyaresearch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03632759
Other Study ID Numbers  ICMJE IRB18-044
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Carla Greenbaum, MD, Benaroya Research Institute
Study Sponsor  ICMJE Carla Greenbaum, MD
Collaborators  ICMJE Juvenile Diabetes Research Foundation
Investigators  ICMJE
Principal Investigator: Carla Greenbaum, MD Benaroya Research Institute
PRS Account Benaroya Research Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP