Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

Phase 2 Terminated 15 enrolled Ionis Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2012-07
Primary completion: 2014-01
Completion: 2014-03

Outcome

Outcome not reported

Stopped (Business): “The study was terminated for business planning purposes. Assessments of APOCIIIRx in this population will be explored in a larger efficacy study”

Publications

Digenio A, Dunbar RL, Alexander VJ, Hompesch M, Morrow L, Lee RG, Graham MJ, Hughes SG, Yu R, Singleton W, Baker BF, Bhanot S, Crooke RM. Antisense-Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes. Diabetes Care. 2016 Aug;39(8):1408-15. doi: 10.2337/dc16-0126. Epub 2016 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Volanesorsen	Antisense oligonucleotide	300 mg	Subcutaneous