Study Stopped
Due to poor enrollment
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
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started Nov 2005
Typical duration for phase_2 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 24, 2006
CompletedFirst Posted
Study publicly available on registry
May 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedDecember 5, 2022
April 1, 2008
1.3 years
May 24, 2006
December 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale - New Haven Hospital
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Isis Pharmaceuticals
Ionis Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 24, 2006
First Posted
May 26, 2006
Study Start
November 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
December 5, 2022
Record last verified: 2008-04