Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes
Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Bladder Cancer
Intervention: Pioglitazone (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Takeda
Summary
To assess the potential association between pioglitazone and bladder cancer compared with
non-pioglitazone users among patients with type 2 diabetes mellitus.
Clinical Details
Official title: Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Incident Diagnosis of Bladder Cancer Identified From the Kaiser Permanente Northern California Cancer Registry From 01 January 1997 to 31 December 2010.
Secondary outcome: Incident Diagnosis of Bladder Cancer, by Time Since Starting PioglitazoneIncident Diagnosis of Bladder Cancer, by Duration of Pioglitazone Therapy Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone Participants With Bladder Cancer by Stage of Cancer Comparison of the Results of the Current Analysis and the 5-Year Interim Report for Incidence of Bladder Cancer Comparison of the Results of the Current Analysis and the 5-Year Interim Report for Incidence of Bladder Cancer, by Time Since Starting Pioglitazone Comparison of the Results of the Current Analysis and the 5-Year Interim Report for Incidence of Bladder Cancer, by Duration of Therapy Comparison of the Results of the Current Analysis and the 5-Year Interim Report for Incidence of Bladder Cancer, by Cumulative Dose
Detailed 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.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
ACTOS® Package Insert 8-year 4th Interim Report 8-year 4th Interim Report (Additional Sensitivity Analysis) 8-year 4th Interim Report (Proteinuria Analysis)
Starting date: July 2004
Last updated: June 19, 2013
|