Phase 2
Completed N=78
Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
Source: ClinicalTrials.gov NCT00300365 ↗Enrolled (actual)
78
Serious AEs
6.4%
Results posted
Jul 2017
Primary outcomePrimary: Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks — 37.4; 36.2; 40.6; 44.2 mg/dL — p=<0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks |
37.4; 36.2; 40.6; 44.2 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Men and women between the ages of 18 and 75
- HDL-C ≤ 40 mg/dL for Men and HDL-C 130/>85 mmHg in untreated patients OR use of any antihypertensive agent.
- Fasting glucose > 100 mg/dL but 150 mg/dL
Exclusion Criteria
- 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).
- 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.
- Uncontrolled hypertension (defined as systolic bp > 180, diastolic BP > 100).
- Triglycerides > 400 mg/dL
- LDL-cholesterol level > 190 mg/dl
- History of chronic renal insufficiency (serum creatinine >2.0 mg/dl).
- History of liver disease or abnormal liver function tests (LFTs) (>2x upper limit normal)
- Hemoglobin < 10 mg/dL
- History of congestive heart failure (NYHA Class III or IV)
- Women who are pregnant or lactating
- History of a non-skin malignancy within the previous 5 years
- Any major active rheumatologic, pulmonary, or dermatologic disease or other chronic inflammatory condition
- Surgery in the last 90 days
- History of HIV positive
- Active alcohol or drug abuse
- Active peptic ulcer disease
- Gout attack within the past 6 months
- Participation in an investigational drug study within 6 weeks
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful study participation
- Subjects on warfarin may be enrolled, but they will be excluded from the optional adipose biopsy.
Data sourced from ClinicalTrials.gov (NCT00300365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.