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Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D

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ClinicalTrials.gov Identifier: NCT03632759
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
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

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

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

Inclusion Criteria:

  1. ≥ 3 years from Type 1 diabetes diagnosis
  2. Peak MMTT stimulated C-peptide <0.017 pmol/mL
  3. Proinsulin levels ≥ 2 pM (either fasting or stimulated)
  4. Females of child-bearing potential must be willing to use effective birth control for 12 weeks
  5. Willing and able to give informed consent for participation
  6. 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, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > 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 liraglutide arm

    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 golimumab arm

    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 any detectable viral DNA on real-time PCR of plasma.
    6. Active infection with CMV, defined by any detectable viral DNA on real-time PCR of plasma.
    7. Any of the following hematologic abnormalities:

      • White blood count <3,000/μL or >14,000/μL
      • Lymphocyte count <500/μL
      • Platelet count <150,000 /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 ClinicalTrials.gov identifier (NCT number): NCT03632759


Contacts
Contact: Marli McCulloch-Olson 1-800-888-4187 diabetes@benaroyaresearch.org

Locations
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
Investigators
Principal Investigator: Carla Greenbaum, MD Benaroya Research Institute

Responsible Party: Carla Greenbaum, MD, Director, Diabetes Program, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT03632759     History of Changes
Other Study ID Numbers: IRB18-044
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Liraglutide
Antibodies, Monoclonal
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors