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

XOMA

Status and phase

Completed

Phase 2

Conditions

Type 1 Diabetes

Treatments

Drug: Xoma 052

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

X052076

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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