Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Isis Pharmaceuticals Identifier:
First received: July 19, 2012
Last updated: October 14, 2013
Last verified: October 2013

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: 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:

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: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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 identifier: NCT01647308

United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Isis Pharmaceuticals Identifier: NCT01647308     History of Changes
Other Study ID Numbers: ISIS 304801-CS4
Study First Received: July 19, 2012
Last Updated: October 14, 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 processed this record on April 20, 2014