Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

Ionis Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: ISIS-APOCIIIRX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01647308

ISIS 304801-CS4

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

15 participants in 2 patient groups, including a placebo group

ISIS-APOCIIIRX

Active Comparator group

Treatment:

Drug: ISIS-APOCIIIRX

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo