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

XOMA

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: XOMA 052

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01144975

X052118

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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