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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
XOMA (US) LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Diabetes, Type 1

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

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

First Posted
October 19, 2009
Last Updated
March 3, 2014
Sponsor
XOMA (US) LLC
Collaborators
Juvenile Diabetes Research Foundation
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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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