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Completed

NCT Number: NCT01144975

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XOMA 052

Drug

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

Drug

Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Registry information

Official study title

A Randomized Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2010
Registry last updated
May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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