Comparing 3 approaches for type 1 diabetes mellitus

Exclusion

• −Known hypersensitivity to tocilizumab, or ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → laboratory findings indicating undue risk of a tocilizumab-related adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →.
• −Active hepatitis B or C infection, positive HIV serology, or any latent or active infection that would interfere with study procedures or be exacerbated by study medications.
• −Type 2 diabetes or other condition requiring exogenous insulin that is not due to autoimmunity, or when insulin delivery is not managed through an AID system.
• −Diabetic complications (e.g., severe/proliferative retinopathy or neuropathy) or a clinically significant medical, cognitive, or psychiatric condition that, in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, poses additional risk or would make consistent study follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → unlikely.
• −Recurrent diabetic ketoacidosis (2 or more events in the 12 months prior to Screening).
• −Clinically significant cardiovascular or cerebrovascular disease, uncontrolled blood pressure, family history of Long QT syndrome, or clinically significant ECG abnormality.
• −Significant history of alcohol or drug abuse, or positive alcohol breath test or urine drug screen at the Screening or Run-in visit.
• −Plans to implement new strenuous physical activity (e.g., significantly increased running pace/duration, high-intensity interval training, heavy weightlifting, vigorous cycling) during the study.
• −Impaired awareness of hypoglycemia.
• −Clinically significant abnormal Screening laboratory or other diagnostic findings (including hepatic, hematologic, thyroid, muscle-enzyme, or tuberculosis screening) rendering the participant unsuitable for the study.
• −Current or recent use of medications that could interfere with glucose metabolism or confound study assessments (e.g., glucocorticoids, systemic beta-blockers, growth hormone, or other antidiabetic medications \[e.g., glucagon-like peptide 1 (GLP-1) receptor agonists and/or sodium-glucose cotransport 2 (SGLT2) inhibitors\]).
• −Vaccination within 30 days prior to dosing or planned vaccination within 8 weeks post-dosing.
• −History of trauma to, or other findings affecting the suitability of, the muscles intended for study intervention administration.
• −Participation in another investigational drug or biologic trial within 6 months prior to Screening, or participation in any previous gene therapy trial
• −Pregnant or breastfeeding.
• −History of malignancy requiring chemotherapy and/or radiation within the 12 months prior to Screening, except for successfully treated non-melanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia, and localized prostate cancer.
• −History of bariatric surgery within the 12 months prior to Screening.