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Completed

NCT Number: NCT00998699

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XOMA 052

Drug

Sterile solution subcutaneously administered every 4 weeks for 12 weeks

Placebo

Drug

Sterile solution subcutaneously administered every 4 weeks for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 20, 2009
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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