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

NCT00513214 | Completed Phase 1 DMC

• 1 other identifier: X052073
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Type 2; Mellitus

Outcome Measures

Primary Outcomes (2)

• Safety assessed by pre- and post-treatment serial measurements of vital signs.

  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.

• Safety assessed by treatment-emergent adverse events.

  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.

Study Arms (2)

XOMA 052

ACTIVE COMPARATOR

Drug: XOMA 052

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XOMA 052 DRUG

* 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).

XOMA 052

Placebo DRUG

* 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• XOMA (US) LLC: lead

Study Sites (4)

Unknown Facility

Escondido, California, 92026, United States

Location

Unknown Facility

Miami Gardens, Florida, 33169, United States

Location

Unknown Facility

Omaha, Nebraska, 68154, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

gevokizumab

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pedro Urquilla, MD

  XOMA (US) LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: February 1, 2010
• Last Updated: October 4, 2011

Record last verified: 2011-09

Locations

US (4)