Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a 12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in non-diabetic patients with the metabolic syndrome (see Table 1).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Kos Pharmaceuticals
• Treatments: Aspirin; Niacin; Niacinamide; Nicotinic Acids; Pioglitazone

Criteria

Inclusion Criteria:

1. Men and women between the ages of 18 and 75

2. HDL-C ≤ 40 mg/dL for Men and HDL-C < 50 mg/dl for Women*

3. At least two of the following criteria (a, b, c, or d) listed below:

1. Abdominal obesity (waist circumference: men 40 inches and women 35 inches)**

2. Blood pressure > 130/>85 mmHg in untreated patients OR use of any antihypertensive agent.

3. Fasting glucose > 100 mg/dL but < 126 mg/dL

4. Fasting triglycerides > 150 mg/dL

Exclusion Criteria:

1. Diabetes or use of anti-hyperglycemic medication in the last 3 months (subjects with a fasting blood glucose of > 110 mg/dL will have an oral glucose tolerance test (OGTT) to rule out diabetes mellitus).

2. Subjects on statin therapy may be enrolled, but only if they have been on a stable dose for at least 3 months, and are not expected to require titration of statin therapy during the course of the study.

3. Uncontrolled hypertension (defined as systolic bp > 180, diastolic BP > 100).

4. Triglycerides > 400 mg/dL

5. LDL-cholesterol level > 190 mg/dl

6. History of chronic renal insufficiency (serum creatinine >2.0 mg/dl).

7. History of liver disease or abnormal liver function tests (LFTs) (>2x upper limit normal)

8. Hemoglobin < 10 mg/dL

9. History of congestive heart failure (NYHA Class III or IV)

10. Women who are pregnant or lactating

11. History of a non-skin malignancy within the previous 5 years

12. Any major active rheumatologic, pulmonary, or dermatologic disease or other chronic inflammatory condition

13. Surgery in the last 90 days

14. History of HIV positive

15. Active alcohol or drug abuse

16. Active peptic ulcer disease

17. Gout attack within the past 6 months

18. Participation in an investigational drug study within 6 weeks

19. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful study participation

20. Subjects on warfarin may be enrolled, but they will be excluded from the optional adipose biopsy.