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

September 30, 2011 updated by: XOMA (US) LLC

A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of the Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Mesa, Arizona, United States
      • Phoenix, Arizona, United States
      • Tempe, Arizona, United States
    • California
      • Chino, California, United States
      • Escondido, California, United States
      • Los Angeles, California, United States
      • Los Gatos, California, United States
      • National City, California, United States
      • Palm Springs, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • Tarzana, California, United States
      • Walunt Creek, California, United States
    • Florida
      • Bradenton, Florida, United States
      • Brooksville, Florida, United States
      • Coral Gables, Florida, United States
      • Deland, Florida, United States
      • Ft. Lauderdale, Florida, United States
      • Hialeah, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Port Orange, Florida, United States
      • St. Petersburg, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
    • Illinois
      • Arlington Heights, Illinois, United States
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Newton, Kansas, United States
    • Maryland
      • Columbia, Maryland, United States
      • Oxon Hill, Maryland, United States
    • Minnesota
      • Edina, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Montana
      • Butte, Montana, United States
    • Nevada
      • Henderson, Nevada, United States
      • Las Vegas, Nevada, United States
    • New York
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Greenville, North Carolina, United States
      • Hickory, North Carolina, United States
      • Statesville, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Wilson, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Kettering, Ohio, United States
      • Lynhurst, Ohio, United States
      • Wadsworth, Ohio, United States
      • Willoughby Hills, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
    • South Carolina
      • Greer, South Carolina, United States
    • Tennessee
      • Kingsport, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Orem, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Burke, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Renton, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Sterile solution subcutaneously administered monthly for 6 months
Experimental: XOMA 052
Drug: XOMA 052
Sterile solution subcutaneously administered monthly for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182
Time Frame: Day 0 pre-dose and Day 182
Day 0 pre-dose and Day 182

Secondary Outcome Measures

Outcome 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.
Time Frame: Day 0 through Day 182
Day 0 through Day 182
Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points
Time Frame: Day 0 pre-dose through Day 182
Day 0 pre-dose through Day 182
Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points
Time Frame: Day 0 pre-dose through Day 182
Day 0 pre-dose through Day 182
Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points
Time Frame: Day 0 pre-dose through Day 182
Day 0 pre-dose through Day 182
Serum levels of XOMA 052 (select sites only)
Time Frame: Day 28 pre-dose, Day 168 pre-dose, and Day 182
Day 28 pre-dose, Day 168 pre-dose, and Day 182

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XOMA (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

October 4, 2011

Last Update Submitted That Met QC Criteria

September 30, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X052078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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