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

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Treatments: Insulin

Criteria

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
• Subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dL, hematocrit of >/= 35%, and HbA1c levels of >/= 6.5% and 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