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  
Number of Participants  
[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  
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 [2]
[units: percentage of participants]
  50.8     57.9     108.7  
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 [3]
[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] Elevated creatinine: Creatinine >1.4 mg/dL for women and >1.5 mg/dL for men.
[2] Includes newly diagnosed patients and patients who newly enrolled in Kaiser Permanente with an existing diagnosis of diabetes mellitus.
[3] Includes use of any other diabetes medications during follow-up.



  Outcome Measures
  Show All Outcome Measures

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
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  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