A 12/24-weeks, open, multi-centre, phase IV study on safety and efficacy of 2mg exenatide once weekly (Bydureon) in T2DM patients. - Bydureon

Exclusion Criteria

• - Has been treated, is currently being treated, or is expected to require
• or undergo treatment with any of the following medications:
• a. Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
• b. Insulin within 2 weeks prior to screening or insulin for longer than 1
• week within 3 months of screening;
• c.DPP-4 inhibitors within 30 days of screening;
• d. Regular use (> 14 days) of drugs that directly affect gastrointestinal
• motility within 3 months of screening;
• e. 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;
• f. 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)