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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01066715
First received: February 8, 2010
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182 [ Time Frame: Day 0 pre-dose and Day 182 ] [ Designated as safety issue: No ]

Secondary 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 through Day 182 ] [ Designated as safety issue: No ]
  • Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points [ Time Frame: Day 0 pre-dose through Day 182 ] [ Designated as safety issue: No ]
  • Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points [ Time Frame: Day 0 pre-dose through Day 182 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Serum levels of XOMA 052 (select sites only) [ Time Frame: Day 28 pre-dose, Day 168 pre-dose, and Day 182 ] [ Designated as safety issue: No ]

Enrollment: 421
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Sterile solution subcutaneously administered monthly for 6 months
Experimental: XOMA 052 Drug: XOMA 052
Sterile solution subcutaneously administered monthly for 6 months

  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 ≥ 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066715

  Show 67 Study Locations
Sponsors and Collaborators
XOMA (US) LLC
  More Information

No publications provided

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01066715     History of Changes
Other Study ID Numbers: X052078
Study First Received: February 8, 2010
Last Updated: September 30, 2011
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 October 16, 2014