Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study hypothesis is that XOMA 052 is likely to improve glycemic control in subjects with Type 2 Diabetes Mellitus.

The purpose of this study is to determine whether XOMA 052 improves glycemic control in subjects on Metformin monotherapy whose diabetes is still not adequately controlled.

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

Details

• Lead Sponsor: XOMA (US) LLC

Criteria

Inclusion Criteria:

• Diagnosed with T2D (disease duration >= 6 months)

• HbA1c measurements >= 7.0% and <= 10.0%

• On a stable regimen of metformin monotherapy

• Age >= 18 and <= 75

• Stable diet and exercise regimen

• BMI <= 40 kg/m2

Exclusion Criteria:

• Significant signs and symptoms of uncontrolled hyperglycemia (i.e., polyuria, polydipsia, or polyphagia)

• Uncontrolled hypertension (systolic > 170 mmHg and/or diastolic > 110 mmHg)

• Known to be positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV

• 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)

• Pulmonary disease requiring medication other than inhaled corticosteroid s

• History of tuberculosis or positive PPD test.

• Active leg, foot, or decubitus ulcer

• Any significant inflammatory, rheumatologic, or systemic autoimmune disease

• History or any symptoms of a demyelinating disease

• History of severe non-proliferative or proliferative retinopathy

Other protocol-defined inclusion/exclusion criteria may apply