Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

XOMA

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo

Drug: XOMA 052

Study type

Interventional

Funder types

Industry

Identifiers

X052078

Details and patient eligibility

About

The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2 Diabetes.

Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c.

Enrollment

421 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with T2D (disease duration ≥ 6 months)
HbA1c ≥ 6.8% and ≤ 10.0%
Have been on a stable regimen of metformin monotherapy for at least 12 weeks prior to Day 0
Willingness to maintain stable diet and exercise regime throughout the study
Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study

Exclusion criteria

Uncontrolled hypertension
History of malignancy within 5 years
History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Advanced stage heart failure (New York Heart Association [NYHA] class 3 or 4)
Clinically significant uncontrolled arrhythmias
History of tuberculosis
Active leg, foot, or decubitus ulcer
Any significant inflammatory, rheumatologic, or systemic autoimmune disease
History of chronic infections
History or any symptoms of a demyelinating disease
Major surgery within 3 months
Female subjects who are pregnant, planning to become pregnant