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

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ClinicalTrials.gov Identifier: NCT00330200
Recruitment Status : Terminated (Due to poor enrollment)
First Posted : May 26, 2006
Last Update Posted : May 1, 2008
Sponsor:
Information provided by:
Ionis Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ISIS 113715 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2006
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
  2. Examine the effect on whole body energy expenditure
  3. Evaluate the effects on fasting and postprandial glucose excursions
  4. Evaluate the effects on hemoglobin A1c (HbA1c)

Secondary Outcome Measures :
  1. Expand the safety and tolerability profile for ISIS 113715
  2. Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover
  3. Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330200


Locations
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United States, Connecticut
Yale - New Haven Hospital
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Investigators
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Study Chair: Isis Pharmaceuticals Ionis Pharmaceuticals, Inc.
More Information
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Responsible Party: Isis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00330200    
Other Study ID Numbers: ISIS 113715-CS11
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: May 1, 2008
Last Verified: April 2008
Keywords provided by Ionis Pharmaceuticals, Inc.:
Fasting plasma glucose
HbA1c
Metabolism
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism