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

May 15, 2012 updated by: XOMA (US) LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 0 pre-dose through Day 420

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 0 pre-dose through Day 420
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
Day 0 pre-dose through Day 420
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
Day 0 pre-dose through Day 420

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XOMA (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X052118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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