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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998699
• Other study ID #: X052076
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2009
• Last updated: March 3, 2014
• Start date: February 2010
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Xoma 052
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
• Placebo
Sterile solution subcutaneously administered every 4 weeks for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
XOMA (US) LLC	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

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