Back to resultsEffects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ISIS 113715
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Fasting plasma glucose, HbA1c, Metabolism
Eligibility Criteria
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
Sites / Locations
- Yale - New Haven Hospital
Outcomes
Primary Outcome Measures
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
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)
Full Information
NCT ID
NCT00330200
First Posted
May 24, 2006
Last Updated
December 1, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00330200
Brief Title
Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
Due to poor enrollment
Study Start Date
November 1, 2005 (Actual)
Primary Completion Date
March 1, 2007 (Actual)
Study Completion Date
March 1, 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ionis Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Fasting plasma glucose, HbA1c, Metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ISIS 113715
Primary Outcome Measure Information:
Title
Evaluate the effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
Title
Examine the effect on whole body energy expenditure
Title
Evaluate the effects on fasting and postprandial glucose excursions
Title
Evaluate the effects on hemoglobin A1c (HbA1c)
Secondary Outcome Measure Information:
Title
Expand the safety and tolerability profile for ISIS 113715
Title
Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover
Title
Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isis Pharmaceuticals
Organizational Affiliation
Ionis Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Yale - New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics
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