Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066715
• Other study ID #: X052078
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2010
• Last updated: September 30, 2011
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• XOMA 052
Sterile solution subcutaneously administered monthly for 6 months
• Placebo
Sterile solution subcutaneously administered monthly for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182		Day 0 pre-dose and Day 182	No
Secondary	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.		Day 0 through Day 182	No
Secondary	Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points		Day 0 pre-dose through Day 182	No
Secondary	Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points		Day 0 pre-dose through Day 182	No
Secondary	Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points		Day 0 pre-dose through Day 182	No
Secondary	Serum levels of XOMA 052 (select sites only)		Day 28 pre-dose, Day 168 pre-dose, and Day 182	No