A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:
1. Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
2. Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
3. DPP-4 inhibitors within 30 days of screening;
4. Regular use (> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;
5. Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of screening;
6. GLP-1 receptor agonist except exenatide within 3 months of screening;
diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;
type 2 diabetes by beta-cell dysfunction requiring insulin treatment
Has ever used exenatide
Pregnant or breast feeding patients
Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal
End-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min)

Arm && Interventions

Group	Intervention	Description
Bydureon	Bydureon	exenatide once weekly

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)	baseline and 12/24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Gloucose	baseline and 12/24 weeks	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)
Change in Body Weight	baseline and 12/24 weeks	Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Change in Vital Sign	baseline and 12/24 weeks	Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Evaluation of "Subjective Improvement of Main Indication"	baseline and 12/24 weeks	"Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."
Change in HbA1c	baseline and 12/24 weeks	Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)