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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00330200
• Other study ID #: ISIS 113715-CS11
• Status: Terminated
• Phase: Phase 2
• Start date: November 1, 2005
• Est. completion date: March 1, 2007

Study information

• Verified date: April 2008
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 1, 2007
• Est. primary completion date: March 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ISIS 113715

Locations

Country	Name	City	State
United States	Yale - New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
Primary	Examine the effect on whole body energy expenditure
Primary	Evaluate the effects on fasting and postprandial glucose excursions
Primary	Evaluate the effects on hemoglobin A1c (HbA1c)
Secondary	Expand the safety and tolerability profile for ISIS 113715
Secondary	Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover
Secondary	Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis)