The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria

• •Patients with type 1 diabetes mellitus (T1DM), diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg Cushing, acromegaly)
• •Need for insulin within the previous 3 months
• •Use of Thiazolidinediones in the previous 4 weeks
• •Significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis).
• •Treatment with systemic steroids and thyroid hormone (unstable dosage).
• •Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.
• •Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
• •Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
• •Significant illness within the two weeks prior to dosing.
• •Past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
• •History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
• •history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
• •history or clinical evidence of pancreatic injury or pancreatitis;
• •history or presence of impaired renal function as indicated by abnormal creatinine or urea val-ues or abnormal urinary constituents (e.g., albuminuria);
• •evidence of urinary obstruction or difficulty in voiding at screening;
• •Polymorphonuclears \<1500/µL at inclusion or platelet count \< 100,000/μL at screening and baseline.
• •History of immunocompromise.
• •Evidence of liver disease as indicated by abnormal transaminases and alkaline phosphatase exceeding twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL).