Metabolic SyndromePhase 2NCT00300365
Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
A Phase 2 study testing Pioglitazone, Niacin ER and Aspirin in people with Metabolic Syndrome, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Pioglitazone, Niacin ER and Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Trial of Pioglitazone and Niacin Extended Release in Non-diabetic Patients With Metabolic Syndrome
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).
Read the detailed description
This is a two-arm, parallel, double-blind randomized prospective clinical trial. The subjects will be asked to provide informed consent, and then undergo screening for enrollment criteria at the first visit (-5 weeks). The subjects who are eligible, and provide informed consent will return for Visit 2 baseline data (-4 weeks), and then begin the unblinded niacin-ER titration. Specifically, subjects will receive a starting dose of niacin-ER of 500 mg per day, which will be increased in 500 mg increments every week up to a dose of 2000 mg per day. Subjects will need to tolerate at least 1500 mg per day of niacin-ER in order to remain in the study and be randomized. Thus subjects who are unable to tolerate the 2000 mg daily dose of niacin-ER will be taken back to 1500 mg per day for one week and then randomized. Subjects who develop prohibitive side effects at doses less than 1500 mg per day will be discontinued from the study. All subjects who are able to take the target dose of niacin-ER will continue that dose of niacin-ER and come to the General Clinical Research Center (GCRC) to be randomized in a 1:1 fashion to either niacin-ER plus pioglitazone or niacin-ER plus matching placebo for 12 weeks. Pioglitazone will be started at 30 mg and then increased to 45 mg at week 6. This entry design is designed to minimize the differences in mean dose of niacin-ER and dropout rate between study groups.
- Conditions
- Metabolic Syndrome
- Being tested
- Pioglitazone, Placebo, Niacin ER, Aspirin
- Keywords
- HDL cholesterol, Metabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
Pioglitazone, initially 30 mg, then titrated to 45 mg/day
PlaceboOther
Pioglitazone placebo
Niacin ERDrug
Niacin ER 2.0 g/day
AspirinDrug
asprin 325 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Active Pioglitazone + Open-Label Niacin | Experimental | Intervention: Pioglitazone, initially 30mg, then titrated to 45mg + niacin ER 2.0 g/day + aspirin 325 mg/day Receives: 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 Receives: Other: Placebo; Drug: Niacin ER; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, after 12 weeks of pioglitazone vs placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Kos Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Rick Samaha, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300365
- Sponsor's protocol ID
- 803751
- Other IDs
- Pionir
- Status last verified
- Jun 2017
- First submitted
- 6 Mar 2006
- Last updated
- 28 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Trial of Pioglitazone and Niacin Extended Release in Non-diabetic Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00300365
- Acronym / sponsor ID
- 803751
- Conditions
- Metabolic Syndrome
- Keywords
- HDL cholesterol, Metabolic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Kos Pharmaceuticals
- Study start
- Nov 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 Mar 2006 (estimated)
- Results
- Posted 28 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a two-arm, parallel, double-blind randomized prospective clinical trial. The subjects will be asked to provide informed consent, and then undergo screening for enrollment criteria at the first visit (-5 weeks). The subjects who are eligible, and provide informed consent will return for Visit 2 baseline data (-4 weeks), and then begin the unblinded niacin-ER titration. Specifically, subjects will receive a starting dose of niacin-ER of 500 mg per day, which will be increased in 500 mg increments every week up to a dose of 2000 mg per day. Subjects will need to tolerate at least 1500 mg per day of niacin-ER in order to remain in the study and be randomized. Thus subjects who are unable to tolerate the 2000 mg daily dose of niacin-ER will be taken back to 1500 mg per day for one week and then randomized. Subjects who develop prohibitive side effects at doses less than 1500 mg per day will be discontinued from the study. All subjects who are able to take the target dose of niacin-ER will continue that dose of niacin-ER and come to the General Clinical Research Center (GCRC) to be randomized in a 1:1 fashion to either niacin-ER plus pioglitazone or niacin-ER plus matching placebo for 12 weeks. Pioglitazone will be started at 30 mg and then increased to 45 mg at week 6. This entry design is designed to minimize the differences in mean dose of niacin-ER and dropout rate between study groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Pioglitazone + Open-Label Niacin | Experimental | Drug: Pioglitazone, Drug: Niacin ER, Drug: AspirinIntervention: Pioglitazone, initially 30mg, then titrated to 45mg + niacin ER 2.0 g/day + aspirin 325 mg/day |
| Placebo +Open-Label Niacin | Placebo comparator | Other: Placebo, Drug: Niacin ER, Drug: AspirinIntervention: Pioglitazone Placebo + 2.0 g/day Open-Label Niacin + 325 mg/day Aspirin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazoneAlso: ActosPioglitazone, initially 30 mg, then titrated to 45 mg/day | Drug | Active Pioglitazone + Open-Label Niacin |
| PlaceboPioglitazone placebo | Other | Placebo +Open-Label Niacin |
| Niacin ERNiacin ER 2.0 g/day | Drug | Active Pioglitazone + Open-Label Niacin, Placebo +Open-Label Niacin |
| Aspirinasprin 325 mg/day | Drug | Active Pioglitazone + Open-Label Niacin, Placebo +Open-Label Niacin |
Primary outcome
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks
Time frame: Baseline, after 12 weeks of pioglitazone vs placebo
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Samaha, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone, Niacin ER and Aspirin in people with Metabolic Syndrome, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks (time frame: Baseline, after 12 weeks of pioglitazone vs placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.