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

NCT00300365 | Completed Phase 2 Results

• 2 other identifiers: 803751Pionir
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metabolic Syndrome

Keywords

HDL cholesterol; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks

  Mean increase in HDL-C from baseline (week -4) to 12 weeks post randomization in non-diabetic subjects with low HDL-C and metabolic syndrome. After baseline, all subjects titrated niacin extended release (ER) to 2 grams (g) daily over 4 weeks. Subjects were also given 325 mg aspirin to take 30 minutes before the niacin ER. After 4 weeks, half of the subjects added blinded pioglitazone 30mg/day (milligrams/day) for 6 weeks followed by 45 mg/day for 6 weeks; the other half added placebo. HDL-C was was assessed at baseline and 12 weeks post randomization

  Baseline, after 12 weeks of pioglitazone vs placebo

Study Arms (2)

Active Pioglitazone + Open-Label Niacin

EXPERIMENTAL

Intervention: Pioglitazone, initially 30mg, then titrated to 45mg + niacin ER 2.0 g/day + aspirin 325 mg/day

Drug: Pioglitazone; Drug: Niacin ER; Drug: Aspirin

Placebo +Open-Label Niacin

PLACEBO COMPARATOR

Intervention: Pioglitazone Placebo + 2.0 g/day Open-Label Niacin + 325 mg/day Aspirin

Other: Placebo; Drug: Niacin ER; Drug: Aspirin

Interventions

Pioglitazone DRUG

Pioglitazone, initially 30 mg, then titrated to 45 mg/day

Also known as: Actos

Active Pioglitazone + Open-Label Niacin

Placebo OTHER

Pioglitazone placebo

Placebo +Open-Label Niacin

Niacin ER DRUG

Niacin ER 2.0 g/day

Active Pioglitazone + Open-Label Niacin; Placebo +Open-Label Niacin

Aspirin DRUG

asprin 325 mg/day

Active Pioglitazone + Open-Label Niacin; Placebo +Open-Label Niacin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 75
• HDL-C ≤ 40 mg/dL for Men and HDL-C \< 50 mg/dl for Women\*
• At least two of the following criteria (a, b, c, or d) listed below:
• Abdominal obesity (waist circumference: men 40 inches and women 35 inches)\*\*
• Blood pressure \> 130/\>85 mmHg in untreated patients OR use of any antihypertensive agent.
• Fasting glucose \> 100 mg/dL but \< 126 mg/dL
• Fasting triglycerides \> 150 mg/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Kos Pharmaceuticals: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Pioglitazone; Aspirin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Richard L. Dunbar
• Organization: University of Pennsylvania

richard.dunbar@uphs.upenn.edu

(215) 315-3378

Study Officials

• Rick Samaha, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pioglitazone and placebo were overencapsulated
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2006
• First Posted: March 8, 2006
• Study Start: November 1, 2005
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 28, 2017
• Results First Posted: July 28, 2017

Record last verified: 2017-06

Locations

US (1)