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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XOMA (US) LLC
• Collaborator: Juvenile Diabetes Research Foundation

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