Overview

This trial is active, not recruiting.

Conditions diabetes, bladder cancer
Treatment pioglitazone
Sponsor Takeda
Collaborator Kaiser Permanente
Start date July 2004
End date December 2013
Trial size 200000 participants
Trial identifier NCT01637935, 01-03-TL-OPI-524, U1111-1132-3482

Summary

To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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.
pioglitazone Actos
Pioglitazone tablets.
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.

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Incident Diagnosis of Bladder Cancer, by Time Since Starting Pioglitazone
time frame: January 1, 1997 to December 31, 2010.
Incident Diagnosis of Bladder Cancer, by Duration of Pioglitazone Therapy
time frame: January 1, 1997 to December 31, 2010.
Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone
time frame: January 1, 1997 to December 31, 2010.
Participants With Bladder Cancer by Stage of Cancer
time frame: January 1, 1997 to December 31, 2010.
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.
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.
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.
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.

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - In the KPNC diabetes registry and who are age 40 or older as of January 1, 1997 or additional registry members who reach age 40 at any point before December 31 2002; patients age 40 or older who enroll in KPNC between January 1, 1997 and December 21 2002 and who are identified as having diabetes; and all KP members age 40 or older who develop diabetes during this time period. Inclusion Criteria for the Sensitivity Analysis - Modified Cohort: - All patients who are in the KPNC Diabetes Registry and who are age 40 or older as of January 1, 1997; - All additional KPNC Diabetes Registry members who reach age 40 at any point before December 31, 2009 and who have been enrolled in KPNC since January 1, 1997 without a gap in membership; - All KPNC members age 40 or older who are newly diagnosed with diabetes between January 1, 1997 and December 31, 2009. The definition of newly diagnosed diabetes requires that the patient be a KPNC member for more than 2 years before being identified as having diabetes according the registry criteria. Exclusion Criteria: - Diagnosis of bladder cancer recorded in the KPNC cancer registry prior to initiation of observation or within 6 months of entry into KPNC. Inclusion Criteria for the Sensitivity Analysis - Modified Cohort: - all patients who are in the KPNC Diabetes Registry and who are age 40 or older as of January 1, 1997; - all additional KPNC Diabetes Registry members who reach age 40 at any point before December 31, 2009 and who have been enrolled in KPNC since January 1, 1997 without a gap in membership; - all KPNC members age 40 or older who are newly diagnosed with diabetes between January 1, 1997 and December 31, 2009. The definition of newly diagnosed diabetes requires that the patient be a KPNC member for more than 2 years before being identified as having diabetes according the registry criteria.

Additional Information

Official title Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes
Description Following guidance from the United States Food and Drug Administration (FDA), the University of Pennsylvania and Kaiser Permanente Northern California (KPNC) designed and is conducting this study from their own database to assess the potential association between pioglitazone and bladder cancer among patients with type 2 diabetes mellitus. The study is being conducted over the course of 10 years, with a series of interim analyses 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 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Takeda.