Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT00513214
First received: August 7, 2007
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of XOMA 052 in subjects with stable Type 2 Diabetes Mellitus (T2D).

The study is a dose-escalation study designed to evaluate route of administration (intravenous or subcutaneous), doses, and dosing regimens for future studies.


Condition Intervention Phase
Type 2 Diabetes
Drug: XOMA 052
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2a, Double-blind, Placebo-controlled Study of the Safety and Pharmacokinetics of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety assessed by pre- and post-treatment serial measurements of vital signs. [ Time Frame: Part 1: Day 0 pre-treatment through Day 56. Part 2: Day 0 pre-treatment through Day 56. Part 3: Day 0 pre-treatment through Day 84. ] [ Designated as safety issue: No ]
  • Safety assessed by treatment-emergent adverse events. [ Time Frame: Part 1: Day 0 post-treatment through Day 56. Part 2: Day 0 post-treatment through Day 56. Part 3: Day 0 post-treatment through Day 84. ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: July 2007
Study Completion Date: February 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: XOMA 052 Drug: XOMA 052
  • Part 1, Single IV infusion at one of six dose levels (mg/kg).
  • Part 2, Single SC injection at one of three dose levels (mg/kg).
  • Part 3, Three biweekly SC injections at one of two dose levels (mg/kg).
Placebo Comparator: Placebo Drug: Placebo
  • Part 1, Single IV infusion at one of six dose levels (mg/kg).
  • Part 2, Single SC injection at one of three dose levels (mg/kg).
  • Part 3, Three biweekly SC injections at one of two dose levels (mg/kg).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Diabetes Association (ADA) diagnostic criteria for T2D - Fasting blood glucose concentration ≥ 126 mg/dL (≥ 7.0 mmol/L) (must be measured within 35 days prior to Day 0) OR Symptoms of hyperglycemia (e.g., thirst, polyuria, weight loss, visual blurring) AND a casual/random plasma glucose value of ≥ 200 mg/dL (≥ 11.1 mmol/L) (must be measured within 35 days prior to Day 0)
  • HbA1c ≥ 7.5% and ≤ 12% (DCCT standard)
  • Current T2D of duration > 6 months at Screening
  • T2D and other diseases must be stable. Stable disease is defined as disease that is judged stable by the investigator and which did not require a change in medications or dosing level on 4 or more consecutive days or 7 days in total within 35 days prior to Day 0.
  • Age ≥ 18 and ≤ 70 at Screening
  • Weight ≥ 80 lbs (36.3 kg) and ≤ 325 lbs (147.4 kg)
  • BMI ≥ 23 and ≤ 40 kg/m2
  • For female subjects of child-bearing age, a negative serum pregnancy test. For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study.
  • Agree not to change diet and exercise regimen during the trial

Exclusion Criteria:

  • Use of the following medications - Anti-inflammatory therapy other than aspirin ≤ 100 mg/day; Immunosuppressive treatment; Beta 2 and non-selective adrenergic blockers (Note: selective beta 1 blockers are permitted); Thiazolidinediones; Glucagon-like peptide (GLP) agonists including DPP4 inhibitors
  • Change in medication for diabetes within 35 days prior to Day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total
  • Fasting C-peptide < 400 pM (< 1.20 μg/L)
  • Hemoglobin < 8.0 g/dL, WBC < 3.0 X 103/mm3, platelet count < 125 X 103/mm3, creatinine > 1.5 mg/dL, AST/ALT > 2 X ULN, alkaline phosphatase > 2 X ULN
  • Positive for GAD65 or IA-2 auto-antibodies
  • Known HIV antibody, hepatitis B surface antigen, and/or hepatitis C antibody
  • History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma
  • Infectious disease - CRP > 30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening; History of recurrent infection or predisposition to infection; Active leg or foot ulcer
  • Immunodeficiency
  • Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
  • History or symptoms of a demyelinating disease
  • Clinically significant diabetic macular edema and/or proliferative diabetic retinopathy by history or fundoscopy
  • Receipt of a live (attenuated) vaccine within 3 months prior to Screening
  • Major surgery within 35 days prior to Day 0
  • Participation in an investigational drug or device trial within 30 days prior to Screening
  • Use of a therapeutic monoclonal antibody within 90 days prior to Screening
  • Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug
  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: NCT00513214

Locations
United States, California
Escondido, California, United States, 92026
United States, Florida
Miami Gardens, Florida, United States, 33169
United States, Nebraska
Omaha, Nebraska, United States, 68154
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
XOMA (US) LLC
Investigators
Study Director: Pedro Urquilla, MD XOMA (US) LLC
  More Information

No publications provided

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT00513214     History of Changes
Other Study ID Numbers: X052073
Study First Received: August 7, 2007
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 August 28, 2014