A Phase I, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

XOMA (US) LLC1 site in 1 country36 target enrollmentSeptember 2007

ConditionsType 2 Diabetes

InterventionsXOMA 052 Placebo

DrugsXOMA 052 Placebo

Overview

Phase: Phase 1
Intervention: XOMA 052
Conditions: Type 2 Diabetes
Sponsor: XOMA (US) LLC
Enrollment: 36
Locations: 1
Primary Endpoint: Glycated hemoglobin (HbA1c) at Days 0 and 28.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

IV administration of XOMA 052 is likely to improve glycemic control in subjects with T2D by blocking certain receptors.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

February 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

XOMA (US) LLC

Eligibility 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 28 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 28 days prior to Day 0)
•HbA1c ≥ 7.5% and ≤ 12% (DCCT standard)
•Current T2D of duration \> 3 months and ≤ 10 years 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 28 days prior to Day
•Age ≥ 18 and ≤ 70 at Screening
•Weight ≥ 80 lbs (36.3 kg) and ≤ 325 lbs (147.4 kg)
•BMI ≥ 23 and ≤ 36 kg/m2
•For female subjects of child-bearing age, a negative serum pregnancy test. For subjects with reproductive potential, a willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during the study.
•Agrees 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 28 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 × 103/mm3, platelet count \< 125 × 103/mm3, creatinine \> 1.5 mg/dL, AST/ALT \> 2 × ULN, alkaline phosphatase \> 2 × ULN
•Positive for GAD65 or IA-2 auto-antibodies
•History or evidence of thyroid abnormalities, including active hyperthyroidism needing medication. Subjects with hypothyroidism will not be excluded if their TSH level has been normal during the 3 months prior to Screening.
•Abnormal T3, T4, thyroglobulin, or TSH levels
•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

Arms & Interventions

1

Intervention: XOMA 052

2

Intervention: Placebo

Outcomes

Primary Outcomes

Glycated hemoglobin (HbA1c) at Days 0 and 28.

Time Frame: Day 0 and Day 28

Secondary Outcomes

Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.(Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.)
Safety assessed by adverse events, vital signs measurements, clinical laboratory assessments, infusion reactions, immune responses to XOMA 052.(Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.)
Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.(Dose groups 1 - 5: Day 0 pre-dose through Day 91. Dose group 6: Day 0 pre-dose through Day 364.)