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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Xoma 052; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
  • Zurich, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Active Comparator: XOMA 052	Drug: Xoma 052; Sterile solution subcutaneously administered every 4 weeks for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in insulin requirements	Day -3 through Day 0 pre-dose and Day 109 through Day 112)
Change in HbA1c levels	Day 0 pre-dose and Day 112
Change in fasting glucose	Day 0 pre-dose and Day 112
Change in fasting glucagon and cortisol	Day 0 pre-dose and Day 112
Change in systemic inflammation markers	Day 0 pre-dose and Day 112
Change in meal-stimulated GLP-1 and GIP	Day 0 pre-dose and Day 112
Change in lipids profile	Day 0 pre-dose and Day 112
Measurement of serum concentrations of XOMA 052	Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364

Collaborators and Investigators

• Sponsor: XOMA (US) LLC
• Collaborators: Juvenile Diabetes Research Foundation
• Investigators: Principal Investigator: Marc Donath, MD, Universitaetsspital Zuerich

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: October 19, 2009
• First Posted (Estimate): October 20, 2009

Study Record Updates

• Last Update Posted (Estimate): March 4, 2014
• Last Update Submitted That Met QC Criteria: March 3, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes; Type 1
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: X052076