Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Type 2, Mellitus
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.
Interventions
DRUGXOMA 052
Sterile solution subcutaneously administered monthly for 6 months
DRUGPlacebo
Sterile solution subcutaneously administered monthly for 6 months
Sponsors
XOMA (US) LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182 | Day 0 pre-dose and Day 182 |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of XOMA 052 (select sites only) | Day 28 pre-dose, Day 168 pre-dose, and Day 182 |
| 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 | Day 0 pre-dose through Day 182 |
| Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points | Day 0 pre-dose through Day 182 |
| Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points | Day 0 pre-dose through Day 182 |
Countries
United States
Outcome results
None listed