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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00998699
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : March 4, 2014
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Xoma 052 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2010
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in insulin requirements [ Time Frame: Day -3 through Day 0 pre-dose and Day 109 through Day 112) ]
  3. Change in HbA1c levels [ Time Frame: Day 0 pre-dose and Day 112 ]
  4. Change in fasting glucose [ Time Frame: Day 0 pre-dose and Day 112 ]
  5. Change in fasting glucagon and cortisol [ Time Frame: Day 0 pre-dose and Day 112 ]
  6. Change in systemic inflammation markers [ Time Frame: Day 0 pre-dose and Day 112 ]
  7. Change in meal-stimulated GLP-1 and GIP [ Time Frame: Day 0 pre-dose and Day 112 ]
  8. Change in lipids profile [ Time Frame: Day 0 pre-dose and Day 112 ]
  9. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998699

Basel, Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Juvenile Diabetes Research Foundation
Principal Investigator: Marc Donath, MD UniversitaetsSpital Zuerich

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT00998699     History of Changes
Other Study ID Numbers: X052076
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Keywords provided by XOMA (US) LLC:
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