Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

This study has been terminated.
(The study was terminated for business planning purposes. Assessments of APOCIIIRx in this population will be explored in a larger efficacy study)
Sponsor:
Information provided by (Responsible Party):
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01647308
First received: July 19, 2012
Last updated: July 11, 2014
Last verified: July 2014
  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:


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


Enrollment: 15
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647308

Locations
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
ClinicalTrials.gov Identifier: NCT01647308     History of Changes
Other Study ID Numbers: ISIS 304801-CS4
Study First Received: July 19, 2012
Last Updated: July 11, 2014
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 July 22, 2014