Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin

A RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL, PLACEBO CONTROLLED STUDY OF THE EFFECT OF OAP-189 ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF METFORMIN IN DIABETIC SUBJECTS.

This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects with type 2 diabetes who are taking metformin for their diabetes.

Inclusion Criteria:

• Subjects must have been diagnosed with type 2 diabetes, with HbA1c level >=7.0% and <=11.0% and a fasting glucose level <=280 mg/dL.
• Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on study day 1.
• Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight >=50 kg.
• Subjects must be otherwise generally healthy, but may be enrolled with a stable chronic illness, if it is well controlled and does not interfere with the primary objective of the study.
• Subjects must currently be treated for diabetes with metformin alone at a total daily dose of >=1gm (administered QD or BID) and that dose must have been stable for at least 4 weeks before study day 1.
• Nonsmoker.

Exclusion Criteria:

• Any significant disease with the exception of diabetes mellitus.
• Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
• Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
• Any clinically important problems in physical examination results, vitals sign measurements, ECGs, or clinical laboratory test results.
• Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
• Positive findings of urine drug screen
• Use of any investigational or non-permitted prescription drug within 30 days before investigational product administration.