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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01637935
First received: July 7, 2012
Last updated: June 19, 2013
Last verified: June 2013
Results First Received: August 31, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pioglitazone Treated Participants treated with pioglitazone, defined as having filled at least two prescriptions for the drug within a 6-month period according to the Kaiser Permanente Northern California (KPNC) pharmacy database.
No Pioglitazone Treatment Participants not treated with pioglitazone defined as not having filled at least two prescriptions for the drug within a 6-month period according to the KPNC pharmacy database.

Participant Flow:   Overall Study
    Pioglitazone Treated     No Pioglitazone Treatment  
STARTED     33416     159683  
COMPLETED     33416     159683  
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.
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Reporting Groups
  Description
Pioglitazone Treated Participants treated with pioglitazone, defined as having filled at least two prescriptions for the drug within a 6-month period according to the Kaiser Permanente Northern California (KPNC) pharmacy database.
No Pioglitazone Treatment Participants not treated with pioglitazone defined as not having filled at least two prescriptions for the drug within a 6-month period according to the KPNC pharmacy database.
Total Total of all reporting groups

Baseline Measures
    Pioglitazone Treated     No Pioglitazone Treatment     Total  
Number of Participants  
[units: participants]
  33416     159683     193099  
Age, Customized  
[units: percentage of participants]
     
40-49 years     29.1     22.1     51.2  
50-59 years     33.1     25.6     58.6  
60-69 years     25.7     26.2     51.9  
70 years and older     12.1     46.5     58.6  
Gender  
[units: percentage of participants]
     
Female     46.6     46.5     93.1  
Male     53.4     53.5     106.9  
Race/Ethnicity, Customized  
[units: percentage of participants]
     
White     51.5     52.2     103.7  
Black     10.3     10.8     21.1  
Asian     14.7     12.8     27.5  
Hispanic     13.4     10.7     24.0  
Other     5.8     5.7     11.5  
Missing     4.4     7.8     12.2  
Current smoker  
[units: percentage of participants]
  20.5     17.4     37.9  
Renal function at baseline [1]
[units: percentage of participants]
     
Normal creatinine     77.3     77.2     154.5  
Elevated creatinine     4.0     8.7     12.7  
Missing     18.7     14.1     32.8  
Congestive heart failure at baseline  
[units: percentage of participants]
  3.0     6.9     9.9  
Baseline Glycosylated Hemoglobin (HbA1c)  
[units: percentage of participants]
     
<7%     16.9     28.6     45.5  
7-7.9%     18.3     19.3     37.6  
8-8.9%     12.9     10.4     23.3  
9-9.9%     9.8     7.0     16.8  
≥10%     24.0     17.1     41.1  
Missing     18.2     17.5     35.7  
Newly diagnosed with diabetes mellitus at the start of follow-up [2]
[units: percentage of participants]
  50.6     57.9     108.5  
Diabetes duration at baseline  
[units: percentage of participants]
     
0-4 years     59.7     62.8     122.5  
5-9 years     9.3     6.0     15.3  
10 or more years     9.2     10.8     20.0  
Missing     21.8     20.4     42.1  
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     8.4     1.5     9.9  
Metformin     84.0     45.0     129.0  
Sulfonylureas     89.1     60.4     149.5  
Other oral hypoglycemic drugs     5.8     1.3     7.1  
Insulin     48.0     28.0     76.0  
[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
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1.  Primary:   Incident Diagnosis of Bladder Cancer Identified From the Kaiser Permanente Northern California Cancer Registry From 01 January 1997 to 31 December 2010.   [ Time Frame: January 1, 1997 to December 31, 2010. ]

2.  Secondary:   Incident Diagnosis of Bladder Cancer, by Time Since Starting Pioglitazone   [ Time Frame: January 1, 1997 to December 31, 2010. ]

3.  Secondary:   Incident Diagnosis of Bladder Cancer, by Duration of Pioglitazone Therapy   [ Time Frame: January 1, 1997 to December 31, 2010. ]

4.  Secondary:   Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone   [ Time Frame: January 1, 1997 to December 31, 2010. ]

5.  Secondary:   Participants With Bladder Cancer by Stage of Cancer   [ Time Frame: January 1, 1997 to December 31, 2010. ]

6.  Secondary:   Comparison of the Results of the Current Analysis and the 5-Year Interim Report for Incidence of Bladder Cancer   [ Time Frame: The 5-year analysis includes data from January 1 1997 to 30 April 2008. The 8-year analysis includes data from January 1, 1997 to December 31, 2010. ]

7.  Secondary:   Comparison of the Results of the Current Analysis and the 5-Year Interim Report for Incidence of Bladder Cancer, by Time Since Starting Pioglitazone   [ Time Frame: The 5-year analysis includes data from January 1 1997 to 30 April 2008. The 8-year analysis includes data from January 1, 1997 to December 31, 2010. ]

8.  Secondary:   Comparison of the Results of the Current Analysis and the 5-Year Interim Report for Incidence of Bladder Cancer, by Duration of Therapy   [ Time Frame: The 5-year analysis includes data from January 1 1997 to 30 April 2008. The 8-year analysis includes data from January 1, 1997 to December 31, 2010. ]

9.  Secondary:   Comparison of the Results of the Current Analysis and the 5-Year Interim Report for Incidence of Bladder Cancer, by Cumulative Dose   [ Time Frame: The 5-year analysis includes data from January 1 1997 to 30 April 2008. The 8-year analysis includes data from January 1, 1997 to December 31, 2010. ]


  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 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.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.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
Study First Received: July 7, 2012
Results First Received: August 31, 2012
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration