Trial Outcomes & Findings for Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes (NCT NCT01156597)
NCT ID: NCT01156597
Last Updated: 2014-11-21
Results Overview
The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation: * Change=\[100%\*(Endpoint value - Baseline Value)/Baseline Value\]
COMPLETED
PHASE3
30 participants
24 weeks
2014-11-21
Participant Flow
Participant milestones
| Measure |
Pioglitazone Group
This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
|
Comparator Group
This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes
Baseline characteristics by cohort
| Measure |
Pioglitazone Group
n=16 Participants
This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
|
Comparator Group
n=14 Participants
This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Hemoglobin A1C
|
7.2 %
STANDARD_DEVIATION 1.3 • n=5 Participants
|
7.8 %
STANDARD_DEVIATION 1.3 • n=7 Participants
|
7.5 %
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
High Density Lipoprotein
|
45.3 mg/dl
STANDARD_DEVIATION 11.2 • n=5 Participants
|
48.0 mg/dl
STANDARD_DEVIATION 8.4 • n=7 Participants
|
46.7 mg/dl
STANDARD_DEVIATION 9.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All subjects that completed the study were used for the final analysis
The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation: * Change=\[100%\*(Endpoint value - Baseline Value)/Baseline Value\]
Outcome measures
| Measure |
Pioglitazone Group
n=13 Participants
This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
|
Comparator Group
n=13 Participants
This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
|
|---|---|---|
|
Increased HDL-Cholesterol and Decreased Triglycerides
% Change in HDL cholesterol at 12 weeks
|
7.9 % Change
Standard Deviation 15.3
|
2.7 % Change
Standard Deviation 9.9
|
|
Increased HDL-Cholesterol and Decreased Triglycerides
% Change in HDL cholesterol at 24 weeks
|
15.7 % Change
Standard Deviation 5.9
|
-1.5 % Change
Standard Deviation 3.8
|
|
Increased HDL-Cholesterol and Decreased Triglycerides
% Change in triglycerides at 12 weeks
|
-10.9 % Change
Standard Deviation 26.6
|
7.4 % Change
Standard Deviation 33.5
|
|
Increased HDL-Cholesterol and Decreased Triglycerides
% Change in triglycerides at 24 weeks
|
-15.4 % Change
Standard Deviation 6.3
|
19.7 % Change
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 24 weeksLipoproteins will be isolated and analyzed using the gradient ultracentrifugation-high pressure liquid chromatography technique to isolate very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL), LDL, and high density lipoprotein (HDL) subfractions. Protein and lipid compositions of HDL is determined
Outcome measures
| Measure |
Pioglitazone Group
n=13 Participants
This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
|
Comparator Group
n=13 Participants
This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
|
|---|---|---|
|
HDL Apolipoprotein Levels at Study End-point
HDL-apoAI at end point
|
65.0 mg/dL
Standard Deviation 0.9
|
65.7 mg/dL
Standard Deviation 7.0
|
|
HDL Apolipoprotein Levels at Study End-point
HDL-apoAII at end point
|
26.6 mg/dL
Standard Deviation 4.8
|
22.6 mg/dL
Standard Deviation 4.3
|
|
HDL Apolipoprotein Levels at Study End-point
HDL-apoCI at end point
|
10.9 mg/dL
Standard Deviation 2.2
|
8.4 mg/dL
Standard Deviation 2.5
|
|
HDL Apolipoprotein Levels at Study End-point
HDL-apoCII at end point
|
3.5 mg/dL
Standard Deviation 1.3
|
2.8 mg/dL
Standard Deviation 1.3
|
|
HDL Apolipoprotein Levels at Study End-point
HDL-apoCIII at end point
|
11.8 mg/dL
Standard Deviation 4.0
|
12.5 mg/dL
Standard Deviation 2.6
|
|
HDL Apolipoprotein Levels at Study End-point
HDL-apoM at end point
|
0.62 mg/dL
Standard Deviation 0.2
|
0.43 mg/dL
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 24 weeksThe ability of serum HDL to remove cholesterol from cultured cells will be assessed as an in vitro method to evaluate a functional changes in HDL mediated by changes due to pioglitazone treatment. Cells were incubated with 2% serum from each study subject diluted in culture medium and incubations were performed for a total of 4 hours. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool as described in detail by de la Llera-Moya et al (de la Llera-Moya M, Drazul-Schrader D, Asztalos BF, Cuchel M, Rader DJ, Rothblat GH. The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages. Arterioscler Thromb Vasc Biol. 2010 Apr;30(4):796-801. doi: 10.1161/ATVBAHA.109.199158. PMID: 20075420).
Outcome measures
| Measure |
Pioglitazone Group
n=13 Participants
This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level
The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
|
Comparator Group
n=13 Participants
This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
|
|---|---|---|
|
Cholesterol Efflux Capacity of HDL
|
1.02 Ratio
Standard Deviation 0.10
|
1.05 Ratio
Standard Deviation 0.07
|
Adverse Events
Pioglitazone Group
Comparator Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Armando J. Mendez, Ph.D.
University of Miami Miller School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60