Clinical trial NCT00998699: Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Diabetes
Type 1
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2009-10-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Day 0 pre-dose and Day 112
Secondary outcomes:
measure: Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
timeFrame: Day 0 (baseline) through Day 364
measure: Change in insulin requirements
timeFrame: Day -3 through Day 0 pre-dose and Day 109 through Day 112)
measure: Change in HbA1c levels
timeFrame: Day 0 pre-dose and Day 112
measure: Change in fasting glucose
timeFrame: Day 0 pre-dose and Day 112
measure: Change in fasting glucagon and cortisol
timeFrame: Day 0 pre-dose and Day 112
measure: Change in systemic inflammation markers
timeFrame: Day 0 pre-dose and Day 112
measure: Change in meal-stimulated GLP-1 and GIP
timeFrame: Day 0 pre-dose and Day 112
measure: Change in lipids profile
timeFrame: Day 0 pre-dose and Day 112
measure: Measurement of serum concentrations of XOMA 052
timeFrame: Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364
Other outcomes:
Locations:
city: Basel
country: Switzerland
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Marc Donath, MD
role: PRINCIPAL_INVESTIGATOR
References: