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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: ISIS 113715


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ISIS 113715|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effects of ISIS 113715 on hepatic and peripheral insulin sensitivity |  |  | 
| Examine the effect on whole body energy expenditure |  |  | 
| Evaluate the effects on fasting and postprandial glucose excursions |  |  | 
| Evaluate the effects on hemoglobin A1c (HbA1c) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expand the safety and tolerability profile for ISIS 113715 |  |  | 
| Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover |  |  | 
| Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fasting plasma glucose, HbA1c, Metabolism