Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes
This study is currently recruiting participants.
Verified May 2013 by Isis Pharmaceuticals
Information provided by (Responsible Party):
First received: July 19, 2012
Last updated: May 29, 2013
Last verified: May 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.
|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
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647308
|Contact: Isis Pharmaceuticalsfirstname.lastname@example.org|
|United States, California|
|Profil Institute for Clinical Research||Recruiting|
|Chula Vista, California, United States, 91911|
|Contact: Denon Alderson 619-409-1257|
|Principal Investigator: Marcus Hompesch|
Sponsors and Collaborators