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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00330200

Enrollment

Registered

2006-05-26

Start date

2005-11-01

Completion date

2007-03-01

Last updated

2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Fasting plasma glucose, HbA1c, Metabolism

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.

Interventions

DRUGISIS 113715

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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)	—
Expand the safety and tolerability profile for ISIS 113715	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026