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
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Active Comparator: 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||
3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.
- Total apoC-III [ Time Frame: 91 Days ]The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels.
- Insulin Sensitivity [ Time Frame: Day 92 ]Change from baseline in insulin sensitivity
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
|United States, California|
|Profil Institute for Clinical Research|
|Chula Vista, California, United States, 91911|