Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control. Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
Preserving Beta-Cell Function With Tocilizumab in New-onset Type 1 Diabetes (ITN058AI)
Staggered enrollment is planned for this trial.
Prior to initiating the study in the pediatric age group (6-17 years old), 30-99 eligible adults (ages 18-45 years) will be randomized 2:1 to tocilizumab or placebo, respectively. Once the first thirty adult participants have completed 12 weeks of treatment, the FDA and Data and Safety Monitoring Board (DSMB) will review available data (e.g., interim analysis) to weigh potential risks and benefits before opening the trial to pediatric participants.
Current status: enrollment restricted to eligible adults (ages 18 - 45 years).
Type 1 Diabetes MellitusNew-onset Type 1 Diabetes MellitusT1DMT1Dinterleukin-6 (IL-6) receptor inhibitor
You can join if…
Open to people ages 6 years to 45 years
Male or female aged 6-45 years*
-*Age eligibility criteria includes subjects:
6 to 17 years of age at time of study enrollment
18 to 45 years of age at time of study enrollment
Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association T1DM criteria, within 100 days of study enrollment
Positive for at least one diabetes-related autoantibody, including but not limited to:
Glutamate decarboxylase (GAD-65)
Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
Insulinoma antigen-2 (IA-2)
Zinc transporter-8 (ZnT8)
Peak stimulated C-peptide level>= 0.2 pmol/mL following a mixed-meal tolerance test(MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization(V0)
Signed informed consent (and informed assent of minor, if applicable).
You CAN'T join if...
Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
History of malignancy or serious uncontrolled cardiovascular, nervous system,pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
Any history of recent serious bacterial, viral, fungal, or other opportunistic infections
Have serologic evidence of current or past HIV (Human immunodeficiency virus),Hepatitis B, or Hepatitis C
Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load>=10,000 copies per mL of whole blood
Active infection with Cytomegalovirus (CMV) as defined by CMV viral load>= 10,000 copies per mL of whole blood
Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or both> 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin> ULN
Current or prior treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status
Current or prior (within last 30 days) use of drugs other than insulin to treat hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones,exenatide, liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
Current use of any medication known to significantly influence glucose tolerance(e.g., atypical antipsychotics, diphenylhydantoin, niacin)
Any of the following hematologic abnormalities, confirmed by repeat tests: