Status:
TERMINATED
Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00330200
Start Date
November 1 2005
End Date
March 1 2007
Last Update
December 5 2022
Active Locations (1)
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1
Yale - New Haven Hospital
New Haven, Connecticut, United States, 06511