Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes
NCT ID: NCT01647308
Last Updated: 2022-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
15 participants
INTERVENTIONAL
2012-07-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ISIS-APOCIIIRX
ISIS-APOCIIIRX
3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.
Placebo
Placebo
3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.
Interventions
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ISIS-APOCIIIRX
3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.
Placebo
3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes Mellitus and on a stable dose of metformin
* Hypertriglyceridemia
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Profil Institute for Clinical Research
Chula Vista, California, United States
Countries
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References
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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.
Other Identifiers
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ISIS 304801-CS4
Identifier Type: -
Identifier Source: org_study_id
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