NCT03632759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2018

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

3.2 years

First QC Date

August 13, 2018

Last Update Submit

January 21, 2022

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL.

    0-to-8 weeks

Study Arms (2)

Liraglutide

EXPERIMENTAL

Participants will receive subcutaneous (SC) liraglutide for 8 weeks

Drug: Liraglutide

Golimumab

EXPERIMENTAL

Participants will receive subcutaneous (SC) golimumab for 8 weeks

Drug: Golimumab

Interventions

LiraglutideDRUG

Participants will receive subcutaneous (SC) liraglutide for 8 weeks

Also known as: Victoza
Liraglutide
GolimumabDRUG

Participants will receive subcutaneous (SC) golimumab for 8 weeks

Also known as: SIMPONI
Golimumab

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Benaroya Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Lord SM, Bahnson HT, Greenbaum CJ, Liljenquist DR, Virostko J, Speake C. Testing a new platform to screen disease-modifying therapy in type 1 diabetes. PLoS One. 2023 Dec 14;18(12):e0293268. doi: 10.1371/journal.pone.0293268. eCollection 2023.

    PMID: 38096190DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutidegolimumab

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Carla Greenbaum, MD

    Benaroya Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: two independent open label, proof of concept studies
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Diabetes Program

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

August 15, 2018

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations

US(2)