NCT01647308

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Jul 2012

Typical duration for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

July 19, 2012

Last Update Submit

January 13, 2022

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Total apoC-III

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

    91 Days

Secondary Outcomes (1)

  • Insulin Sensitivity

    Day 92

Study Arms (2)

ISIS-APOCIIIRX

ACTIVE COMPARATOR
Drug: ISIS-APOCIIIRX

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ISIS-APOCIIIRXDRUG

3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.

ISIS-APOCIIIRX
PlaceboDRUG

3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

Related Publications (1)

  • 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.

    PMID: 27271183DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 23, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations

US(1)