Trial Outcomes & Findings for Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL (NCT NCT00300365)
NCT ID: NCT00300365
Last Updated: 2017-07-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline, after 12 weeks of pioglitazone vs placebo
Results posted on
2017-07-28
Participant Flow
Subjects were recruited and participated in the study from December 2005 and July 2007. Subjects were recruited from the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center.
4 weeks prior to randomization, subjects titrated to 2.0 g/day of niacin extended release. Subjects who could not tolerate niacin were excluded from the study.
Participant milestones
| Measure |
Pioglitazone Placebo + Open-Label Niacin + Aspirin
Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and aspirin 325 mg
|
Active Pioglitazone + Open-Label Niacin + Aspirin
Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and aspirin 325 mg. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
40
|
|
Overall Study
COMPLETED
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Pioglitazone Placebo + Open-Label Niacin + Aspirin
Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and aspirin 325 mg
|
Active Pioglitazone + Open-Label Niacin + Aspirin
Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and aspirin 325 mg. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
Baseline characteristics by cohort
| Measure |
Pioglitazone Placebo + Open-Label Niacin + Aspirin
n=38 Participants
Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
|
Active Pioglitazone + Open-Label Niacin + Asprin
n=40 Participants
Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, after 12 weeks of pioglitazone vs placeboPopulation: All subjects for whom HDL-C measurements were recorded at baseline (week -4) and 12 weeks post randomization to placebo, niacin ER, and aspirin or pioglitazone, niacin ER, and aspirin
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
Outcome measures
| Measure |
Pioglitazone Placebo + Open-Label Niacin + Aspirin
n=34 Participants
Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
|
Active Pioglitazone + Open-Label Niacin + Asprin
n=38 Participants
Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
|
|---|---|---|
|
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks
Baseline HDL-C
|
37.4 mg/dL
Interval 36.0 to 38.8
|
36.2 mg/dL
Interval 34.8 to 37.6
|
|
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks
HDL-C 12 weeks Post Randomization
|
40.6 mg/dL
Interval 38.8 to 42.6
|
44.2 mg/dL
Interval 42.2 to 46.2
|
Adverse Events
Pioglitazone Placebo + Open-Label Niacin + Aspirin
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Active Pioglitazone + Open-Label Niacin + Asprin
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone Placebo + Open-Label Niacin + Aspirin
n=38 participants at risk
Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
|
Active Pioglitazone + Open-Label Niacin + Asprin
n=40 participants at risk
Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for Depression
|
0.00%
0/38 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
2.5%
1/40 • Number of events 1 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Shortness of Breath
|
2.6%
1/38 • Number of events 1 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
0.00%
0/40 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/38 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
2.5%
1/40 • Number of events 1 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
|
Gastrointestinal disorders
Small Intestinal Bleed
|
2.6%
1/38 • Number of events 1 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
0.00%
0/40 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Surgery for Back
|
2.6%
1/38 • Number of events 1 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
0.00%
0/40 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
Other adverse events
| Measure |
Pioglitazone Placebo + Open-Label Niacin + Aspirin
n=38 participants at risk
Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
|
Active Pioglitazone + Open-Label Niacin + Asprin
n=40 participants at risk
Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Leg Edema
|
15.8%
6/38 • Number of events 6 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
15.0%
6/40 • Number of events 8 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
|
Skin and subcutaneous tissue disorders
Flushing
|
10.5%
4/38 • Number of events 4 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
17.5%
7/40 • Number of events 7 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
|
Skin and subcutaneous tissue disorders
Itching
|
15.8%
6/38 • Number of events 6 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
5.0%
2/40 • Number of events 2 • Adverse events were recorded from screening (week -4) to completion of study (week 12), for a total of 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place