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Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

This study is currently recruiting participants.
Verified May 2013 by Isis Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01647308
First received: July 19, 2012
Last updated: May 29, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the effects of ISIS ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects with Type 2 Diabetes on stable treatment with metformin.


Condition Intervention Phase
Type 2 Diabetes
 Drug: ISIS-APOCIIIRX
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Investigate the Effects of ISIS 304801 Lowering of ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isis Pharmaceuticals:

Primary Outcome Measures:
  • Total apoC-III [ Time Frame: 91 Days ] [ Designated as safety issue: No ]
    The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels.


Secondary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: Day 92 ] [ Designated as safety issue: No ]
    Change from baseline in insulin sensitivity


Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ISIS-APOCIIIRX Drug: ISIS-APOCIIIRX
3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.
Placebo Comparator: Placebo Drug: Placebo
3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >/= 25 to </= 40 kg/m2
  • Type 2 Diabetes Mellitus and on a stable dose of metformin
  • Hypertriglyceridemia

Exclusion Criteria:

  • Significant abnormalities in medical history, clinical examination or clinical testing
  • Use of oral anti-diabetic medication other than metformin within 3 months prior to dosing
  • History of outpatient insulin use for more than 2 weeks in the last year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647308

Contacts
Contact: Isis Pharmaceuticals 800-679-4747 info@isisph.com

Locations
United States, California
Profil Institute for Clinical Research Recruiting
Chula Vista, California, United States, 91911
Contact: Denon Alderson     619-409-1257        
Principal Investigator: Marcus Hompesch            
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Isis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01647308     History of Changes
Other Study ID Numbers: ISIS 304801-CS4
Study First Received: July 19, 2012
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013