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

NCT01144975 | Completed Phase 2

• 1 other identifier: X052118
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Type 2; Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

XOMA 052

ACTIVE COMPARATOR

Drug: XOMA 052

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XOMA 052 DRUG

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)

XOMA 052

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• XOMA (US) LLC: lead

Study Sites (1)

Unknown Facility

Mexico City, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

gevokizumab

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

ME (1)