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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental | Participants will receive subcutaneous (SC) liraglutide for 8 weeks |
|
| Golimumab | Experimental | Participants will receive subcutaneous (SC) golimumab for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Participants will receive subcutaneous (SC) liraglutide for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL. | 0-to-8 weeks |
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Inclusion Criteria:
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)
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:
Receipt of live vaccine (in the 6 weeks before treatment)
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| Name | Affiliation | Role |
|---|---|---|
| Carla Greenbaum, MD | Benaroya Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States | ||
| Benaroya Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38096190 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| C529000 | golimumab |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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two independent open label, proof of concept studies
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| Golimumab | Drug | Participants will receive subcutaneous (SC) golimumab for 8 weeks |
|
|
| Seattle |
| Washington |
| 98101 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |