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Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01647308
Recruitment Status : Terminated (The study was terminated for business planning purposes. Assessments of APOCIIIRx in this population will be explored in a larger efficacy study)
First Posted : July 23, 2012
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: ISIS-APOCIIIRX Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Total apoC-III [ Time Frame: 91 Days ]
    The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels.


Secondary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: Day 92 ]
    Change from baseline in insulin sensitivity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT01647308


Locations
United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01647308     History of Changes
Other Study ID Numbers: ISIS 304801-CS4
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014

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