Type 2 Diabetes
Conditions
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.
Interventions
DRUGISIS-APOCIIIRX
3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.
DRUGPlacebo
3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total apoC-III | 91 Days | The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity | Day 92 | Change from baseline in insulin sensitivity |
Countries
United States
Outcome results
None listed