Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

NCT01066715 | Completed Phase 2 DMC

• 1 other identifier: X052078
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 67

Brief Summary

The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2 Diabetes. Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Type 2; Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182

  Day 0 pre-dose and Day 182

Secondary Outcomes (5)

• 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 through Day 182

• Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points

  Day 0 pre-dose through Day 182

• Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points

  Day 0 pre-dose through Day 182

• Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points

  Day 0 pre-dose through Day 182

• Serum levels of XOMA 052 (select sites only)

  Day 28 pre-dose, Day 168 pre-dose, and Day 182

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

XOMA 052

EXPERIMENTAL

Drug: XOMA 052

Interventions

XOMA 052 DRUG

Sterile solution subcutaneously administered monthly for 6 months

XOMA 052

Placebo DRUG

Sterile solution subcutaneously administered monthly for 6 months

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 ≥ 6.8% and ≤ 10.0%
• Have been on a stable regimen of metformin monotherapy for at least 12 weeks prior to Day 0
• Willingness to maintain stable diet and exercise regime throughout the study
• Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study

You may not qualify if:

• Uncontrolled hypertension
• History of malignancy within 5 years
• 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)
• Clinically significant uncontrolled arrhythmias
• History of tuberculosis
• Active leg, foot, or decubitus ulcer
• Any significant inflammatory, rheumatologic, or systemic autoimmune disease
• History of chronic infections
• History or any symptoms of a demyelinating disease
• Major surgery within 3 months
• Female subjects who are pregnant, planning to become pregnant

Sponsors & Collaborators

• XOMA (US) LLC: lead

Study Sites (67)

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Huntsville, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Chino, California, United States

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Escondido, California, United States

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Los Angeles, California, United States

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Los Gatos, California, United States

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National City, California, United States

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Palm Springs, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Tarzana, California, United States

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Walunt Creek, California, United States

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Bradenton, Florida, United States

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Brooksville, Florida, United States

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Coral Gables, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Port Orange, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Newton, Kansas, United States

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Columbia, Maryland, United States

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Oxon Hill, Maryland, United States

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Edina, Minnesota, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Hickory, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Wilson, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Kettering, Ohio, United States

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Lynhurst, Ohio, United States

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Wadsworth, Ohio, United States

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Willoughby Hills, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Greer, South Carolina, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Orem, Utah, United States

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West Jordan, Utah, United States

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Burke, Virginia, United States

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Virginia Beach, Virginia, United States

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Renton, Washington, United States

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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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 4, 2011

Record last verified: 2011-09

Locations

US (67)