Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Xoma 052
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Diabetes, Type 1
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
XOMA 052
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
Change in insulin requirements
Change in HbA1c levels
Change in fasting glucose
Change in fasting glucagon and cortisol
Change in systemic inflammation markers
Change in meal-stimulated GLP-1 and GIP
Change in lipids profile
Measurement of serum concentrations of XOMA 052
Full Information
NCT ID
NCT00998699
First Posted
October 19, 2009
Last Updated
March 3, 2014
Sponsor
XOMA (US) LLC
Collaborators
Juvenile Diabetes Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00998699
Brief Title
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
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XOMA (US) LLC
Collaborators
Juvenile Diabetes Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Diabetes, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XOMA 052
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xoma 052
Intervention Description
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Change in insulin requirements
Time Frame
Day -3 through Day 0 pre-dose and Day 109 through Day 112)
Title
Change in HbA1c levels
Time Frame
Day 0 pre-dose and Day 112
Title
Change in fasting glucose
Time Frame
Day 0 pre-dose and Day 112
Title
Change in fasting glucagon and cortisol
Time Frame
Day 0 pre-dose and Day 112
Title
Change in systemic inflammation markers
Time Frame
Day 0 pre-dose and Day 112
Title
Change in meal-stimulated GLP-1 and GIP
Time Frame
Day 0 pre-dose and Day 112
Title
Change in lipids profile
Time Frame
Day 0 pre-dose and Day 112
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Donath, MD
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Principal Investigator
Facility Information:
City
Basel
Country
Switzerland
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
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