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Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes

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ClinicalTrials.gov Identifier: NCT01156597
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : November 11, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Armando J Mendez, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Type 2 Diabetes Mellitus
Intervention Drug: pioglitazone
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pioglitazone Group Comparator Group
Hide Arm/Group Description

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

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.
Period Title: Overall Study
Started 16 14
Completed 13 13
Not Completed 3 1
Arm/Group Title Pioglitazone Group Comparator Group Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
58.4  (5.9) 58.2  (8.2) 58.3  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
6
  37.5%
2
  14.3%
8
  26.7%
Male
10
  62.5%
12
  85.7%
22
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
Hemoglobin A1C  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 16 participants 14 participants 30 participants
7.2  (1.3) 7.8  (1.3) 7.5  (1.2)
High Density Lipoprotein  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 16 participants 14 participants 30 participants
45.3  (11.2) 48.0  (8.4) 46.7  (9.8)
1.Primary Outcome
Title Increased HDL-Cholesterol and Decreased Triglycerides
Hide Description

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]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed the study were used for the final analysis
Arm/Group Title Pioglitazone Group Comparator Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: % Change
% Change in HDL cholesterol at 12 weeks 7.9  (15.3) 2.7  (9.9)
% Change in HDL cholesterol at 24 weeks 15.7  (5.9) -1.5  (3.8)
% Change in triglycerides at 12 weeks -10.9  (26.6) 7.4  (33.5)
% Change in triglycerides at 24 weeks -15.4  (6.3) 19.7  (11.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pioglitazone Group, Comparator Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments The percent change of HDL and triglycerides from baseline between groups was evaluated by ANOVA using baseline, 12 week and 24 week values
2.Secondary Outcome
Title HDL Apolipoprotein Levels at Study End-point
Hide Description Lipoproteins 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
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Group Comparator Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
HDL-apoAI at end point 65.0  (0.9) 65.7  (7.0)
HDL-apoAII at end point 26.6  (4.8) 22.6  (4.3)
HDL-apoCI at end point 10.9  (2.2) 8.4  (2.5)
HDL-apoCII at end point 3.5  (1.3) 2.8  (1.3)
HDL-apoCIII at end point 11.8  (4.0) 12.5  (2.6)
HDL-apoM at end point 0.62  (0.2) 0.43  (0.2)
3.Secondary Outcome
Title Cholesterol Efflux Capacity of HDL
Hide Description The 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).
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Group Comparator Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: Ratio
1.02  (0.10) 1.05  (0.07)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pioglitazone Group Comparator Group
Hide Arm/Group Description

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

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.
All-Cause Mortality
Pioglitazone Group Comparator Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pioglitazone Group Comparator Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pioglitazone Group Comparator Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Armando J. Mendez, Ph.D.
Organization: University of Miami Miller School of Medicine
Phone: 305-243-5342
Responsible Party: Armando J Mendez, University of Miami
ClinicalTrials.gov Identifier: NCT01156597     History of Changes
Other Study ID Numbers: 06-009A
First Submitted: July 2, 2010
First Posted: July 5, 2010
Results First Submitted: April 18, 2014
Results First Posted: November 11, 2014
Last Update Posted: November 21, 2014