This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
456
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit
Change in HbA1c from Visit 1 to each visit up to open-ended study termination
Time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in body weight from Visit 1 to each protocol visit
Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
Time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in fasting plasma glucose from Visit 1 to each protocol visit
Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
Time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in lipids from Visit 1 to each protocol visit
Change in lipids from Visit 1 to each visit up to open-ended study termination
Time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
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Research Site
Birmingham, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Bellflower, California, United States
Research Site
Burlingame, California, United States
Research Site
Chula Vista, California, United States
Research Site
Concord, California, United States
Research Site
Encino, California, United States
Research Site
Fremont, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Gatos, California, United States
...and 50 more locations