Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 19, 2012
July 11, 2014
July 2012
January 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01647308 on ClinicalTrials.gov Archive Site
Insulin Sensitivity [ Time Frame: Day 92 ] [ Designated as safety issue: No ]
Change from baseline in insulin sensitivity
Same as current
Not Provided
Not Provided
 
Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: ISIS-APOCIIIRX
    3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.
  • Drug: Placebo
    3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.
  • Active Comparator: ISIS-APOCIIIRX
    Intervention: Drug: ISIS-APOCIIIRX
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
March 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01647308
ISIS 304801-CS4
No
Isis Pharmaceuticals
Isis Pharmaceuticals
Not Provided
Not Provided
Isis Pharmaceuticals
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP