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

A Randomized Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01144975

Enrollment

Registered

2010-06-16

Start date

2010-05-31

Completion date

2011-10-31

Last updated

2012-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes, Type 2, Mellitus

Brief 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.

Interventions

DRUGXOMA 052

Sterile solution, dose level varies by dose group and study drug administration day, SC injections administered by study personnel at time points specified in the protocol (the subject will receive a total of 8 injections)

DRUGPlacebo

Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, daily fasting blood glucose measured by the subject using a glucose monitor, and treatment-emergent adverse events.	Day 0 pre-dose through Day 420

Secondary

Measure	Time frame
Pharmacokinetic assessments of XOMA 052 from serum samples collected at time points specified in the protocol.	Day 0 pre-dose through Day 420
Anti-inflammatory activity measured by hs-CRP and cytokines collected at time points specified in the protocol.	Day 0 pre-dose through Day 420
Anti-diabetic activity measured by HbA1c, FPG, OGTT, C-peptide, and insulin collected at time points specified in the protocol.	Day 0 pre-dose through Day 420

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026