Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

Part of paid clinical trials in San Francisco, California.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT00947427
Phase
PHASE2
Status
Completed

Conditions

  • Canakinumab in Type 1 Diabetes
  • Newly Diagnosed Type 1 Diabetes
  • Preservation of Insulin Secretion
  • Type 1 Diabetes

Eligibility Criteria

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

Interventions

  • canakinumab (anti IL-1beta) — DRUG
    canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
  • Placebo — DRUG
    Placebo subcutaneous injections

Study Details

Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine. The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive standard intensive diabetes treatment with insulin and dietary management. Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12 injections over one year. All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. Enrollment is expected to occur over two years.

Key Dates

Start date
Oct 31, 2010
Status verified
Apr 2020
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo solution given by subcutaneous injection on monthly basis for 12 months
  • Experimental: Canakinumab
    Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months

Primary Outcome Measure

C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo [ Time Frame: 12 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California-San FranciscoSan FranciscoCalifornia94143-
Stanford UniversityStanfordCalifornia94305-
Yale Medical SchoolNew HavenConnecticut--
University of FloridaGainesvilleFlorida32610--
University of Miami School of MedicineMiamiFlorida33136-
Indiana University-Riley Hospital for ChildrenIndianapolisIndiana46202-
University of MinnesotaMinneapolisMinnesota57931-
Columbia UniversityNew YorkNew York--
University of PittsburghPittsburghPennsylvania15213-
University of Texas-Southwestern Medical SchoolDallasTexas75235-
Benaroya Research InstituteSeattleWashington98101-

Find similar trials in San Francisco, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of California-San Francisco· San Francisco, CAStanford University· Stanford, CAYale Medical School· New Haven, CTUniversity of Florida· Gainesville, FLUniversity of Miami School of Medicine· Miami, FLIndiana University-Riley Hospital for Children· Indianapolis, IN

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