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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Pioglitazone Group   Comparator Group
STARTED   16   14 
COMPLETED   13   13 
NOT COMPLETED   3   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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 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 Total of all reporting groups

Baseline Measures
   Pioglitazone Group   Comparator Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.4  (5.9)   58.2  (8.2)   58.3  (5.9) 
Gender 
[Units: Participants]
     
Female   6   2   8 
Male   10   12   22 
Region of Enrollment 
[Units: Participants]
     
United States   16   14   30 
Hemoglobin A1C 
[Units: %]
Mean (Standard Deviation)
 7.2  (1.3)   7.8  (1.3)   7.5  (1.2) 
High Density Lipoprotein 
[Units: Mg/dl]
Mean (Standard Deviation)
 45.3  (11.2)   48.0  (8.4)   46.7  (9.8) 


  Outcome Measures

1.  Primary:   Increased HDL-Cholesterol and Decreased Triglycerides   [ Time Frame: 24 weeks ]

2.  Secondary:   HDL Apolipoprotein Levels at Study End-point   [ Time Frame: 24 weeks ]

3.  Secondary:   Cholesterol Efflux Capacity of HDL   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: a.mendez@miami.edu


Publications:

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