Text Size

Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Dana King, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00770367
First received: October 9, 2008
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
Results First Received: July 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Diabetes
Interventions: Drug: Pioglitazone then Placebo
Drug: Placebo then Pioglitazone

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
medical clinic, 36 participants recruited

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After informed consent, a laboratory specimen will be obtained at the visit, including a pregnancy test (if indicated), and the screening ADMA level. This information will be used to determine study eligibility. Screened participants will be eligible if their ADMA > 0.50 μM/L. If not eligible would be excluded from study.

Reporting Groups
  Description
Pioglitazone This is the analysis period during which participants took Pioglitazone.
Placebo The analysis period during which participant took the placebo.

Participant Flow for 3 periods

 Period 1:   First Intervention
    Pioglitazone     Placebo  
STARTED     18     18  
COMPLETED     18     16  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 2  

Period 2:   Washout Period of 4 Weeks
    Pioglitazone     Placebo  
STARTED     18     16  
COMPLETED     18     15  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  

Period 3:   Second Intervention
    Pioglitazone     Placebo  
STARTED     18     15  
COMPLETED     16     15  
NOT COMPLETED     2     0  
Lost to Follow-up                 2                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Pioglitazone This is the analysis period during which participants took Pioglitazone.
Placebo The analysis period during which participant took the placebo.
Total Total of all reporting groups

Baseline Measures
    Pioglitazone     Placebo     Total  
Number of Participants  
[units: participants]
 		  18     18     36  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     18     18     36  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  52.2  ± 1.89     55.7  ± 2.42     54  ± 1.56  
Gender  
[units: participants]
 		     
Female     7     8     15  
Male     11     10     21  
Region of Enrollment  
[units: participants]
 		     
United States     18     18     36  



  Outcome Measures

1.  Primary:   Asymmetric Dimethylarginine (ADMA) Level   [ Time Frame: 3 months ]
  Show Outcome Measure 1

2.  Secondary:   NOx f2-isoprostanes   [ Time Frame: 3 months ]
Results not yet posted.   Anticipated Posting Date:   12/2010   Safety Issue:   No


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dana King MD
Organization: Medical University of South Carolina
phone: 843-792-8112
e-mail: kingde@musc.edu


No publications provided


Responsible Party: Dana King, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00770367     History of Changes
Other Study ID Numbers: Takeda 07-060, 18379
Study First Received: October 9, 2008
Results First Received: July 8, 2010
Last Updated: December 2, 2011
Health Authority: United States: Institutional Review Board