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Completed

NCT Number: NCT01066715

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.

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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

Huntsville, Alabama, United States

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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 ≥ 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

Treatment and study plan

XOMA 052

Drug

Sterile solution subcutaneously administered monthly for 6 months

Placebo

Drug

Sterile solution subcutaneously administered monthly for 6 months

Primary outcomes

  1. Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182

    Time frame: Day 0 pre-dose and Day 182

Secondary 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 through Day 182

  2. Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points

    Time frame: Day 0 pre-dose through Day 182

  3. Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points

    Time frame: Day 0 pre-dose through Day 182

  4. 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

  5. Serum levels of XOMA 052 (select sites only)

    Time frame: Day 28 pre-dose, Day 168 pre-dose, and Day 182

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2010
Registry last updated
Oct 4, 2011

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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