Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D

C

Carla Greenbaum, MD

Status and phase

Completed
Early Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Liraglutide
Drug: Golimumab

Study type

Interventional

Funder types

Other

Identifiers

NCT03632759
IRB18-044

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Liraglutide
Experimental group
Description:
Participants will receive subcutaneous (SC) liraglutide for 8 weeks
Treatment:
Drug: Liraglutide
Golimumab
Experimental group
Description:
Participants will receive subcutaneous (SC) golimumab for 8 weeks
Treatment:
Drug: Golimumab

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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