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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144975
• Other study ID #: X052118
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2010
• Last updated: May 15, 2012
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• XOMA 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)
• Placebo
Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetic assessments of XOMA 052 from serum samples collected at time points specified in the protocol.		Day 0 pre-dose through Day 420	No
Secondary	Anti-inflammatory activity measured by hs-CRP and cytokines collected at time points specified in the protocol.		Day 0 pre-dose through Day 420	No
Secondary	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	No