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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Liraglutide Drug: Golimumab Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Targeting Beta Cell Dysfunction in Longstanding T1D
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Liraglutide
Participants will receive subcutaneous (SC) liraglutide for 8 weeks
Drug: Liraglutide
Participants will receive subcutaneous (SC) liraglutide for 8 weeks
Other Name: Victoza

Experimental: Golimumab
Participants will receive subcutaneous (SC) golimumab for 8 weeks
Drug: Golimumab
Participants will receive subcutaneous (SC) golimumab for 8 weeks
Other Name: SIMPONI

Primary Outcome Measures :
  1. Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL. [ Time Frame: 0-to-8 weeks ]

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:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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): NCT03632759

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Contact: Marli McCulloch-Olson 1-800-888-4187

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United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center Not yet recruiting
Idaho Falls, Idaho, United States, 83404
United States, Washington
Benaroya Research Institute Recruiting
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Carla Greenbaum, MD
Juvenile Diabetes Research Foundation
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Principal Investigator: Carla Greenbaum, MD Benaroya Research Institute
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Responsible Party: Carla Greenbaum, MD, Director, Diabetes Program, Benaroya Research Institute Identifier: NCT03632759    
Other Study ID Numbers: IRB18-044
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists