Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

Phase 2

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: ISIS-APOCIIIRX

• Registration Number: NCT01647308
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-23
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Disposition First Submitted: 2018-06-21
• Disposition First Submitted QC: 2018-06-26
• Disposition First Posted: 2018-06-28
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ISIS-APOCIIIRX	ISIS-APOCIIIRX	-

Primary Outcome Measures

Name	Time	Method
Total apoC-III	91 Days	The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels.

Secondary Outcome Measures

Name	Time	Method
Insulin Sensitivity	Day 92	Change from baseline in insulin sensitivity

Trial Locations

Locations (1)

Profil Institute for Clinical Research; 🇺🇸 Chula Vista, California, United States