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

Ionis Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: ISIS 113715

Study type

Interventional

Funder types

Industry

Identifiers

NCT00330200

ISIS 113715-CS11

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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