Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes
|ClinicalTrials.gov Identifier: NCT01637935|
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : October 12, 2012
Last Update Posted : January 18, 2016
|Condition or disease||Intervention/treatment|
|Diabetes Bladder Cancer||Drug: Pioglitazone|
Following guidance from the United States Food and Drug Administration (FDA) and European Medicines Agency, the University of Pennsylvania and Kaiser Permanente Northern California (KPNC) designed and conducted this study using the KPNC database to assess the potential association between pioglitazone and bladder cancer among patients with type 2 diabetes mellitus.
The study was conducted over the course of 10 years, with a series of interim analyses undertaken during this period and provided to the sponsor (Takeda) and the appropriate regulatory agencies.
In 2011, the planned 5-year interim analysis of this study was published in Diabetes Care. That report included data from 1 January 1997 to 30 April 2008. Following reporting of these data, there was a request from the FDA for an additional fourth interim analysis at 8 years including data from 1 January 1997 to 31 December 2010.
In August 2011 the FDA requested inclusion of a sensitivity analysis to assess change of cohort entry criteria to minimize left censoring of exposure. Included in the FDA request was a duration analysis for other antidiabetic medications.
In August 2014, the final 10-year analyses were completed and submitted to the sponsor and regulatory agencies.
Interim results previously posted on clinicaltrials.gov are available in the public archive
|Study Type :||Observational|
|Actual Enrollment :||193099 participants|
|Official Title:||Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes|
|Study Start Date :||July 2004|
|Primary Completion Date :||August 2014|
|Study Completion Date :||August 2014|
Pioglitazone exposed group
Defined as those patients having filled at least two prescriptions for pioglitazone within a 6-month period. Patients in the pioglitazone group may also have exposure to other diabetic medications
Other Name: Actos
Pioglitazone unexposed group
Defined as patients who did not fill at least two prescriptions for pioglitazone within a 6-month period. Patients in the pioglitazone unexposed group may have been exposed to other diabetic medications. This group also included diabetic patients without any diabetic medications.
- Incident Diagnosis of Bladder Cancer (10-year Analysis) [ Time Frame: January 1, 1997 to December 31, 2012 ]Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.
- Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis) [ Time Frame: January 1, 1997 to December 31, 2012 ]
- Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis) [ Time Frame: January 1, 1997 to December 31, 2012 ]
- Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis) [ Time Frame: January 1, 1997 to December 31, 2012 ]
- Stage of Bladder Cancer (10 Year Analysis) [ Time Frame: January 1, 1997 to December 31, 2012 ]