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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01144975
First received: June 14, 2010
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: XOMA 052
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by XOMA (US) LLC:

Primary Outcome Measures:
  • 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 pre-dose through Day 420 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic assessments of XOMA 052 from serum samples collected at time points specified in the protocol. [ Time Frame: Day 0 pre-dose through Day 420 ] [ Designated as safety issue: No ]
  • Anti-inflammatory activity measured by hs-CRP and cytokines collected at time points specified in the protocol. [ Time Frame: Day 0 pre-dose through Day 420 ] [ Designated as safety issue: No ]
  • Anti-diabetic activity measured by HbA1c, FPG, OGTT, C-peptide, and insulin collected at time points specified in the protocol. [ Time Frame: Day 0 pre-dose through Day 420 ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: XOMA 052 Drug: XOMA 052
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)
Placebo Comparator: Placebo Drug: Placebo
Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144975

Locations
Mexico
Mexico City, Mexico
Sponsors and Collaborators
XOMA (US) LLC
  More Information

No publications provided

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01144975     History of Changes
Other Study ID Numbers: X052118
Study First Received: June 14, 2010
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by XOMA (US) LLC:
Diabetes
Type 2
Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013