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Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ISIS-APOCIIIRX
Placebo
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI >/= 25 to </= 40 kg/m2
  • Type 2 Diabetes Mellitus and on a stable dose of metformin
  • Hypertriglyceridemia

Exclusion Criteria:

  • Significant abnormalities in medical history, clinical examination or clinical testing
  • 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

Sites / Locations

  • Profil Institute for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ISIS-APOCIIIRX

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Total apoC-III
The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels.

Secondary Outcome Measures

Insulin Sensitivity
Change from baseline in insulin sensitivity

Full Information

First Posted
July 19, 2012
Last Updated
January 13, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01647308
Brief Title
Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated for business planning purposes. Assessments of APOCIIIRx in this population will be explored in a larger efficacy study
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ISIS-APOCIIIRX
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ISIS-APOCIIIRX
Intervention Description
3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.
Primary Outcome Measure Information:
Title
Total apoC-III
Description
The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels.
Time Frame
91 Days
Secondary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Change from baseline in insulin sensitivity
Time Frame
Day 92

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI >/= 25 to </= 40 kg/m2 Type 2 Diabetes Mellitus and on a stable dose of metformin Hypertriglyceridemia Exclusion Criteria: Significant abnormalities in medical history, clinical examination or clinical testing 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
Facility Information:
Facility Name
Profil Institute for Clinical Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27271183
Citation
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.
Results Reference
derived

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Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

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