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

This study is ongoing, but not recruiting participants.
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: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
 Drug: Xoma 052
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by XOMA (US) LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: February 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: XOMA 052 Drug: Xoma 052
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Sterile solution subcutaneously administered every 4 weeks for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998699

Locations
Switzerland
Basel, Switzerland
Zurich, Switzerland
Sponsors and Collaborators
XOMA (US) LLC
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Marc Donath, MD UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT00998699     History of Changes
Other Study ID Numbers: X052076
Study First Received: October 19, 2009
Last Updated: February 28, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by XOMA (US) LLC:
Diabetes
Type 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 13, 2013