Safety and Efficacy of XOMA 052 in Subjects With Type 2 D... | NCT01066715

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Feb 8, 2010

First Submission Date that Met QC Criteria

Feb 8, 2010

First Posted Date

Feb 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2011

Last Update Posted Date

Oct 4, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

421Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
XOMA 052	Experimental		Drug: XOMA 052

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XOMA 052	Drug	Sterile solution subcutaneously administered monthly for 6 months	XOMA 052

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182		Day 0 pre-dose and Day 182

Secondary Outcomes

Measure	Description	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.		Day 0 through Day 182
Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama		United States

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases