Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes
40 Years
N/A
Both
Diabetes, Bladder Cancer
Trial Information
Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Incident Diagnosis of Bladder Cancer Identified From the Kaiser Permanente Northern California Cancer Registry From 01 January 1997 to 31 December 2010.
Outcome Description:
Incident bladder cancers were identified from the KPNC cancer registry from January 1, 1997 to December 31, 2010. This was supplemented by case identification through surveillance of electronic pathology reports within KPNC for the period from January 1, 2005 to December 31, 2010. Incidence is reported as the number of newly diagnosed cases of bladder cancer per 100,000 person years. The 95% confidence interval was calculated using the Poisson method.
Outcome Time Frame:
January 1, 1997 to December 31, 2010.
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
01-03-TL-OPI-524
NCT ID:
NCT01637935
Start Date:
July 2004
Completion Date:
December 2013
Related Keywords:
- Diabetes
- Bladder Cancer
- Drug therapy
- Urinary Bladder Neoplasms
- Diabetes Mellitus
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