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
  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:


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 ]

Enrollment: 22
Study Start Date: February 2010
Study Completion Date: August 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 3, 2014
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 July 23, 2014