Rituximab in New Onset Type 1 Diabetes

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT00279305
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot maintain proper blood glucose levels in response to daily activities such as eating or exercise. With fewer insulin producing cells blood glucose increases, causing hunger, thirst, and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta cells have already been destroyed. However, this also means that between 10-20% of these cells remain that continue to produce insulin. Scientists have learned that two types of immune cells, B cells and T cells, are involved in causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells that make insulin. Although they don't attack insulin producing cells, B cells may be what trigger the T cells to attack. This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration (FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the immune system are well understood through its use in organ transplantation. Research has shown that rituximab might be helpful in treating other conditions caused by T cells and B cells, including type 1 diabetes. The goal of this study is to find out if rituximab can preserve residual insulin secretion and prevent further beta cell destruction in type 1 diabetes.

Key Dates

Start date
Aug 31, 2005
Status verified
Apr 2020
Primary completion
Apr 30, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
87 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab Intravenous Infusion
    Participants will receive active rituximab (anti-CD20 monoclonal antibody) as an intravenous infusion, with 4 administrations at weeks 0, 1, 2, and 3 at a dose of 375mg/m2
  • Placebo Comparator: Placebo Intravenous Infusion
    Participants will receive placebo given as an intravenous infusion with 4 administrations at weeks 0, 1, 2, and 3.

Primary Outcome Measure

Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year [ Time Frame: When all participants complete the 1 year visit ]

Locations (13)

FacilityCityStateZIPSite coordinators
Childrens Hospital of Los AngelesLos AngelesCalifornia90027-
University of California-San FranciscoSan FranciscoCalifornia94143-
Stanford UniversityStanfordCalifornia94305-
Barbara Davis Center for Childhood DiabetesAuroraColorado80010-
University of FloridaGainesvilleFlorida32610-0296-
University of MiamiMiamiFlorida33136-
Indiana University-Riley Hospital for ChildrenIndianapolisIndiana46202-
JoslinBostonMassachusetts02215-
University of MinnesotaMinneapolisMinnesota55455-
Columbia UniversityNew YorkNew York10032-
University of PittsburghPittsburghPennsylvania15213-
University of TexasDallasTexas75235-8858-
Benaroya Research InstituteSeattleWashington98101-

Find similar trials in Los Angeles, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Childrens Hospital of Los Angeles· Los Angeles, CAUniversity of California-San Francisco· San Francisco, CAStanford University· Stanford, CABarbara Davis Center for Childhood Diabetes· Aurora, COUniversity of Florida· Gainesville, FLUniversity of Miami· Miami, FL

Related Studies