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Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Department of Epidemiology at University of Pennsylvania
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01637935
First received: July 7, 2012
Last updated: December 9, 2015
Last verified: December 2015
Results First Received: August 31, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Diabetes
Bladder Cancer
Intervention: Drug: Pioglitazone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not applicable (database study)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable (database study)

Reporting Groups
  Description
Pioglitazone Exposed Group Patients ever exposed to pioglitazone.
Pioglitazone Unexposed Group Patients never exposed to pioglitazone.

Participant Flow:   Overall Study
    Pioglitazone Exposed Group   Pioglitazone Unexposed Group
STARTED   34181   158918 
COMPLETED   34181   158918 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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 Exposed Group Patients ever exposed to pioglitazone.
Pioglitazone Unexposed Group Patients never exposed to pioglitazone.
Total Total of all reporting groups

Baseline Measures
   Pioglitazone Exposed Group   Pioglitazone Unexposed Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 34181   158918   193099 
Age, Customized 
[Units: Percentage of participants]
     
40-49 years   29.2   22.1   51.3 
50-59 years   33.0   25.6   58.6 
60-69 years   25.7   26.2   51.9 
70 years and older   12.0   26.1   38.1 
Gender 
[Units: Percentage of participants]
     
Female   46.5   46.5   93 
Male   53.5   53.5   107 
Race/Ethnicity, Customized 
[Units: Percentage of participants]
     
White   51.3   52.3   103.6 
Black   10.2   10.8   21 
Asian   14.8   12.8   27.6 
Hispanic   13.4   10.6   24 
Other   5.9   5.7   11.6 
Missing   4.3   7.8   12.1 
Current smoker 
[Units: Percentage of participants]
 20.4   17.4   37.8 
Renal function at baseline [1] 
[Units: Percentage of participants]
     
Normal creatinine   77.4   77.1   154.5 
Elevated creatinine   4.0   8.7   12.7 
Missing   18.6   14.1   32.7 
[1] Elevated creatinine: Creatinine >1.4 mg/dL for women and >1.5 mg/dL for men.
Congestive heart failure at baseline 
[Units: Percentage of participants]
 3.0   6.9   9.9 
Baseline Glycosylated Hemoglobin (HbA1c) 
[Units: Percentage of participants]
     
<7%   17.1   28.6   45.7 
7-7.9%   18.3   19.3   37.6 
8-8.9%   12.8   10.4   23.2 
9-9.9%   9.7   7.0   16.7 
≥10%   23.9   17.1   41 
Missing   18.1   17.5   35.6 
Newly diagnosed with diabetes mellitus at the start of follow-up [1] 
[Units: Percentage of participants]
 50.8   57.9   108.7 
[1] Includes newly diagnosed patients and patients who newly enrolled in Kaiser Permanente with an existing diagnosis of diabetes mellitus.
Diabetes duration at baseline 
[Units: Percentage of participants]
     
0-4 years   60.1   62.8   122.9 
5-9 years   9.2   6.0   15.2 
10 or more years   9.1   10.9   20 
Missing   21.6   20.4   42 
Other cancer prior to baseline 
[Units: Percentage of participants]
 3.1   5.3   8.4 
Other diabetes medications [1] 
[Units: Percentage of participants]
     
Other thiazolidinediones   8.2   1.5   9.7 
Metformin   84.8   45.9   130.7 
Sulfonylureas   89.8   61.2   151 
Other oral hypoglycemic drugs   6.4   1.4   7.8 
Insulin   52.7   29.4   82.1 
Never treated with any diabetes medication   0.0   14.3   14.3 
[1] Includes use of any other diabetes medications during follow-up.


  Outcome Measures
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1.  Primary:   Incident Diagnosis of Bladder Cancer (10-year Analysis)   [ Time Frame: January 1, 1997 to December 31, 2012 ]

2.  Secondary:   Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)   [ Time Frame: January 1, 1997 to December 31, 2012 ]

3.  Secondary:   Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)   [ Time Frame: January 1, 1997 to December 31, 2012 ]

4.  Secondary:   Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)   [ Time Frame: January 1, 1997 to December 31, 2012 ]

5.  Secondary:   Stage of Bladder Cancer (10 Year Analysis)   [ Time Frame: January 1, 1997 to December 31, 2012 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  More Information
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Head, Pharmacoepidemiology
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com


Publications of Results:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01637935     History of Changes
Other Study ID Numbers: 01-03-TL-OPI-524
U1111-1132-3482 ( Registry Identifier: WHO )
Study First Received: July 7, 2012
Results First Received: August 31, 2012
Last Updated: December 9, 2015
Health Authority: United States: Food and Drug Administration