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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01066715

Run by

XOMA (US) LLC

People needed

421

Starts

2010-01-01

Expected to finish

2011-07-01

Last updated by the study team

2011-10-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Chino, California, United States
• Study site — Escondido, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — National City, California, United States
• Study site — Palm Springs, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Tarzana, California, United States
• Study site — Walunt Creek, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Brooksville, Florida, United States
• Study site — Coral Gables, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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