Clinical trial NCT01066715: Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Type 2
Mellitus
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182
timeFrame: Day 0 pre-dose and Day 182
Secondary outcomes:
measure: 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.
timeFrame: Day 0 through Day 182
measure: Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points
timeFrame: Day 0 pre-dose through Day 182
measure: Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points
timeFrame: Day 0 pre-dose through Day 182
measure: Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points
timeFrame: Day 0 pre-dose through Day 182
measure: Serum levels of XOMA 052 (select sites only)
timeFrame: Day 28 pre-dose, Day 168 pre-dose, and Day 182
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Chino
country: United States
state: California
city: Escondido
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: National City
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Walunt Creek
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Newton
country: United States
state: Kansas
city: Columbia
country: United States
state: Maryland
city: Oxon Hill
country: United States
state: Maryland
city: Edina
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Wilson
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Lynhurst
country: United States
state: Ohio
city: Wadsworth
country: United States
state: Ohio
city: Willoughby Hills
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Greer
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Orem
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Burke
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
Study officials:
References: