Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

Phase 2TerminatedNCT01647308

Ionis Pharmaceuticals, Inc.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

ISIS-APOCIIIRXDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Profil Institute for Clinical Research

Chula Vista, California, United States

Outcomes

Primary Outcomes

Total apoC-III

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

Time frame: 91 Days

Secondary Outcomes

Insulin Sensitivity

Change from baseline in insulin sensitivity

Time frame: Day 92

Data from ClinicalTrials.gov

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