Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

Inclusion Criteria:

- Is male or female and 18 to 65 years of age, inclusive, at screening

- Has a history of T2DM and a stable dose of metformin

- Has HbA1c levels at screening between 7% and 10%

Exclusion Criteria:

- Is pregnant or lactating

- Has type 1 diabetes

- Has a significant change in body weight in the 3 months before screening

- Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening

- Has an estimated glomerular filtration rate rate <75 mL/min/1.73 m2 or has ≥75
mL/min/1.73 m2 albumin to urine creatinine ratio >30 mg/g.

- Has alanine aminotransferase or aspartate aminotransferase values >2.0 × upper limit
of normal or total bilirubin >1.5 × upper limit of normal unless the subject has a
known history of Gilbert's syndrome

- Has fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) or >250 mg/dL (>2.85
mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to
screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type
I, IV or V hyperlipidemia will be excluded.

- Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease,
partial bypass or gastric banding

- Has any acute illness within 5 days before first study drug administration

- Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history
of pancreatitis

- Is a heavy tobacco user(more than 10 cigarettes a day)

- Is a heavy alcohol user

- Has a positive screen for drugs of abuse