Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT00998699
First received: October 19, 2009
Last updated: March 3, 2014
Last verified: March 2014

October 19, 2009
March 3, 2014
February 2010
August 2013   (final data collection date for primary outcome measure)
Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose) [ Time Frame: Day 0 pre-dose and Day 112 ] [ Designated as safety issue: No ]
Change in beta -cell function as measured by change in C-peptide level
Complete list of historical versions of study NCT00998699 on ClinicalTrials.gov Archive Site
  • Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events. [ Time Frame: Day 0 (baseline) through Day 364 ] [ Designated as safety issue: No ]
  • Change in insulin requirements [ Time Frame: Day -3 through Day 0 pre-dose and Day 109 through Day 112) ] [ Designated as safety issue: No ]
  • Change in HbA1c levels [ Time Frame: Day 0 pre-dose and Day 112 ] [ Designated as safety issue: No ]
  • Change in fasting glucose [ Time Frame: Day 0 pre-dose and Day 112 ] [ Designated as safety issue: No ]
  • Change in fasting glucagon and cortisol [ Time Frame: Day 0 pre-dose and Day 112 ] [ Designated as safety issue: No ]
  • Change in systemic inflammation markers [ Time Frame: Day 0 pre-dose and Day 112 ] [ Designated as safety issue: No ]
  • Change in meal-stimulated GLP-1 and GIP [ Time Frame: Day 0 pre-dose and Day 112 ] [ Designated as safety issue: No ]
  • Change in lipids profile [ Time Frame: Day 0 pre-dose and Day 112 ] [ Designated as safety issue: No ]
  • Measurement of serum concentrations of XOMA 052 [ Time Frame: Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well-controlled Type 1 Diabetes

The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration.

The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 1 Diabetes
  • Drug: Xoma 052
    Sterile solution subcutaneously administered every 4 weeks for 12 weeks
  • Drug: Placebo
    Sterile solution subcutaneously administered every 4 weeks for 12 weeks
  • Active Comparator: XOMA 052
    Intervention: Drug: Xoma 052
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Stable Type 1 diabetes of > 2 year duration
  • No clinically significant change in treatment regimen for T1D
  • Age ≥ 18 years and ≤ 55 years
  • HbA1c < 7.0%
  • Positive GAD65 and/or IA-2 auto-antibodies
  • Peak C-peptide > 100 pM following IV injection of 1 mg glucagon
  • Body-mass index (BMI) > 18 and < 28 kg/m2
  • Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study

Exclusion criteria:

  • Current infection or history of infection
  • Positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
  • History of tuberculosis or positive PPD test
  • Presence of foot, leg, or decubitus ulcers
  • Current immunosuppressive treatment or documented immunodeficiency
  • History of severe allergic or anaphylactic reactions
  • History of asthma requiring systemic corticosteroid therapy
  • Coronary intervention (PCI, stent placement) or hospitalization for cardiovascular condition within the last 12 months
  • Uncontrolled hypertension
  • History of congestive heart failure (NYHA Class III or IV)
  • History of a coronary event within the last 12 months
  • Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
  • History of malignancy within the last 5 years
  • Receipt of a live (attenuated) vaccine within the last 3 months

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00998699
X052076
Yes
XOMA (US) LLC
XOMA (US) LLC
Juvenile Diabetes Research Foundation
Principal Investigator: Marc Donath, MD UniversitaetsSpital Zuerich
XOMA (US) LLC
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP