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The study was terminated for business planning purposes. Assessments of APOCIIIRx in this population will be explored in a larger efficacy study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISIS-APOCIIIRX | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISIS-APOCIIIRX | Drug | 3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total apoC-III | The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels. | 91 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Change from baseline in insulin sensitivity | Day 92 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research | Chula Vista | California | 91911 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27271183 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | 3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks. |
|
| D004700 | Endocrine System Diseases |