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

Phase 2

Terminated

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00330200
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-01
• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-26
• Primary Completion: 2007-03-01
• Study Completion: 2007-03-01
• Status Verified: 2008-04
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the effects on fasting and postprandial glucose excursions
Evaluate the effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
Evaluate the effects on hemoglobin A1c (HbA1c)
Examine the effect on whole body energy expenditure

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Yale - New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States