Type 1 Diabetes MellitusEarly Phase 1NCT03632759
Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
A Early Phase 1 study testing Liraglutide and Golimumab in people with Type 1 Diabetes Mellitus, run by Carla Greenbaum, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Liraglutide and Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2018to 9 Nov 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥ 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%
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Benaroya Research Institute
Seattle, Washington, 98101
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Liraglutide, Golimumab
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
Participants will receive subcutaneous (SC) liraglutide for 8 weeks
GolimumabDrug
Also called SIMPONI
Participants will receive subcutaneous (SC) golimumab for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Participants will receive subcutaneous (SC) liraglutide for 8 weeks Receives: Drug: Liraglutide |
| Golimumab | Experimental | Participants will receive subcutaneous (SC) golimumab for 8 weeks Receives: Drug: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL.
Measured: 0-to-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start15 Aug 2018
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- two independent open label, proof of concept studies
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carla Greenbaum, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor-investigator, Carla Greenbaum, MD, Benaroya Research Institute
- Investigators
- Carla Greenbaum, MD, Principal investigator, Benaroya Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632759
- Sponsor's protocol ID
- IRB18-044
- Status last verified
- Jan 2022
- First submitted
- 13 Aug 2018
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38096190
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Beta Cell Dysfunction in Longstanding T1D
- ClinicalTrials.gov ID
- NCT03632759
- Acronym / sponsor ID
- IRB18-044
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Carla Greenbaum, MDUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two independent open label, proof of concept studies
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideParticipants will receive subcutaneous (SC) liraglutide for 8 weeks |
| Golimumab | Experimental | Drug: GolimumabParticipants will receive subcutaneous (SC) golimumab for 8 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: VictozaParticipants will receive subcutaneous (SC) liraglutide for 8 weeks | Drug | Liraglutide |
| GolimumabAlso: SIMPONIParticipants will receive subcutaneous (SC) golimumab for 8 weeks | Drug | Golimumab |
Primary outcome
Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL.
Time frame: 0-to-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 38096190Lord 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Greenbaum, MD principal investigator
Benaroya Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Liraglutide and Golimumab in people with Type 1 Diabetes Mellitus, run by Carla Greenbaum, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL. (time frame: 0-to-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.