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NCT01647308 Clinical Trial

Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01647308
Other study ID # ISIS 304801-CS4
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 2012
Est. completion date March 2014

Study information
Verified date January 2022
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 15
Est. completion date March 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
United States Profil Institute for Clinical Research Chula Vista California

Sponsors (1)
Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total apoC-III The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels. 91 Days
Secondary Insulin Sensitivity Change from baseline in insulin sensitivity Day 92
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