As current study is conducted to provide additional information regarding safety and efficacy Bydureon, exenatide once weekly for injectable suspension, in the Korean population open label, non-comparative, multi-centre design is used.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
exenatide once weekly
Research Site
Busan, South Korea
Research Site
Daegu, South Korea
Research Site
Daejeon, South Korea
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
was to estimate the incidence rates of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with 2 mg exenatide once weekly for type 2 diabetes mellitus in the normal clinical practice setting over a period of 12/24 weeks for long-term surveillance.
Time frame: baseline and 12/24 weeks
Change in HbA1c
Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Time frame: baseline and 12/24 weeks
Change in Fasting Plasma Gloucose
Change in Fasting plasma gloucose at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Time frame: baseline and 12/24 weeks
Change in Body Weight
Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Time frame: baseline and 12/24 weeks
Change in Vital Sign
Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Time frame: baseline and 12/24 weeks
Evaluation of "Subjective Improvement of Main Indication"
"Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."
Time frame: baseline and 12/24 weeks
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Research Site
Gwangju, South Korea
Research Site
Incheon, South Korea
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
...and 5 more locations