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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XOMA (US) LLC
• Treatments: Metformin

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply