Type 1 Diabetes Clinical Trial
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
Verified date | March 2014 |
Source | XOMA (US) LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
XOMA (US) LLC | Juvenile Diabetes Research Foundation |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Day 0 pre-dose and Day 112 | No | |
Secondary | Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events. | Day 0 (baseline) through Day 364 | No | |
Secondary | Change in insulin requirements | Day -3 through Day 0 pre-dose and Day 109 through Day 112) | No | |
Secondary | Change in HbA1c levels | Day 0 pre-dose and Day 112 | No | |
Secondary | Change in fasting glucose | Day 0 pre-dose and Day 112 | No | |
Secondary | Change in fasting glucagon and cortisol | Day 0 pre-dose and Day 112 | No | |
Secondary | Change in systemic inflammation markers | Day 0 pre-dose and Day 112 | No | |
Secondary | Change in meal-stimulated GLP-1 and GIP | Day 0 pre-dose and Day 112 | No | |
Secondary | Change in lipids profile | Day 0 pre-dose and Day 112 | No | |
Secondary | Measurement of serum concentrations of XOMA 052 | Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364 | No |
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