Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
Completed · Early Phase 1
Conditions studied: Type 1 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03632759
- Run by
- Carla Greenbaum, MD
- People needed
- 16
- Starts
- 2018-08-15
- Expected to finish
- 2021-11-09
- Last updated by the study team
- 2022-01-24
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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%
You may not qualify if…
- 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
Where it is running
- Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
- Benaroya Research Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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