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

Therapuetic Areas:Endocrinology
Age Range:18 - 65
Start Date:December 2011

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A Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 2 Study to Determine the Tolerability, Pharmacokinetics, and Pharmacodynamics of the GLP 1 Agonist HM11260C in Adult Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

The purpose of this study is to investigate the safety and tolerability of repeated doses of
HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on
stable metformin monotherapy.

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
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Ohio, OH
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