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
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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014