Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics

A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of ISIS 113715 Monotherapy on Insulin Sensitivity, Glucose and Lipid Metabolism and Energy Expenditure in Subjects With Type 2 Diabetes Mellitus

The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus.

Inclusion Criteria:

• Male or female (post menopausal and/or surgically sterile)
• Aged 18 to 70 years
• Treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dL, hematocrit of >/= 35% and HbA1c levels of >/= 7% and </= 10.0%
• Subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dL, hematocrit of >/= 35%, and HbA1c levels of >/= 6.5% and </= 9.0%

Exclusion Criteria:

• Greater than 3 severe hypoglycemic episodes within six months of screen
• Pregnant, breastfeeding, or intends to become pregnant
• Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT greater than 1.5 times the upper limit of normal
• History of hepatitis B surface antigen, hepatitis C antibody, or HIV
• Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
• Clinically significant and currently active diseases
• Clinically significant abnormalities in medical history, physical examination, or laboratory examination