- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632759
Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
January 21, 2022 updated by: Carla Greenbaum, MD
Targeting Beta Cell Dysfunction in Longstanding T1D
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Idaho
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Idaho Falls, Idaho, United States, 83404
- Rocky Mountain Diabetes and Osteoporosis Center
-
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Washington
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Seattle, Washington, United States, 98101
- Benaroya Research Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ 3 years from Type 1 diabetes diagnosis
- Males and females 18-50 years of age, inclusive
- Peak MMTT stimulated C-peptide <0.017 pmol/mL
- Proinsulin levels ≥ 2 pM (either fasting or stimulated)
- Females of child-bearing potential must be willing to use effective birth control for 12 weeks
- Willing and able to give informed consent for participation
- HbA1c ≤ 8.5%
Exclusion Criteria:
- Concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of screening MMTT (V-2).
- History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies.
- 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) .
- Females who are pregnant or lactating.
- Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment.
- History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac and stable thyroid disease.
- Current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin).
- Any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial.
For Study A (liraglutide)
- Any history of pancreatitis or elevated amylase or lipase.
- Any personal or family history of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).
- Any personal or family history of multiple endocrine neoplasia syndrome type 2.
- Hypersensitivity to liraglutide.
- Previous treatment with liraglutide.
- Known history of clinically significant gastroparesis.
For Study B (golimumab)
- Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections.
- Any history of demyelinating diseases (such as multiple sclerosis), heart failure, or left ventricular dysfunction.
- Serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C.
- Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection.
- Active infection with EBV, defined by real-time PCR.
- Active infection with CMV, defined by real-time PCR.
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
- Receipt of live vaccine (in the 6 weeks before treatment)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liraglutide
Participants will receive subcutaneous (SC) liraglutide for 8 weeks
|
Participants will receive subcutaneous (SC) liraglutide for 8 weeks
Other Names:
|
Experimental: Golimumab
Participants will receive subcutaneous (SC) golimumab for 8 weeks
|
Participants will receive subcutaneous (SC) golimumab for 8 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL.
Time Frame: 0-to-8 weeks
|
0-to-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carla Greenbaum, MD, Benaroya Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2018
Primary Completion (Actual)
November 9, 2021
Study Completion (Actual)
November 9, 2021
Study Registration Dates
First Submitted
August 13, 2018
First Submitted That Met QC Criteria
August 13, 2018
First Posted (Actual)
August 15, 2018
Study Record Updates
Last Update Posted (Actual)
January 24, 2022
Last Update Submitted That Met QC Criteria
January 21, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Tumor Necrosis Factor Inhibitors
- Liraglutide
- Golimumab
Other Study ID Numbers
- IRB18-044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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