Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes
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ClinicalTrials.gov Identifier: NCT01637935 |
Recruitment Status
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Completed
First Posted
: July 11, 2012
Results First Posted
: October 12, 2012
Last Update Posted
: March 7, 2018
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Tracking Information | |||
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First Submitted Date | July 7, 2012 | ||
First Posted Date | July 11, 2012 | ||
Results First Submitted Date | August 31, 2012 | ||
Results First Posted Date | October 12, 2012 | ||
Last Update Posted Date | March 7, 2018 | ||
Study Start Date | July 2004 | ||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT01637935 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Not Provided | ||
Current Other Outcome Measures | Not Provided | ||
Original Other Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes | ||
Official Title | Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes | ||
Brief Summary | To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus. | ||
Detailed Description | 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 |
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Study Type | Observational | ||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||
Biospecimen | Not Provided | ||
Sampling Method | Probability Sample | ||
Study Population | The study was conducted within Kaiser Permanente Northern California (KPNC), which provides comprehensive healthcare services to approximately 3.2 million members. The source population was identified from the KPNC diabetes registry, which was first constructed in 1993 and has been updated annually since then. The registry identifies patients primarily from four data sources: primary hospital discharge diagnoses of diabetes mellitus (since 1971); two or more outpatient visit diagnoses of diabetes (since 1995); any prescription for a diabetes-related medication (since 1994); or any record of an abnormal hemoglobin A1c (HbA1c) test (>6.7%) (since 1991). The diabetes registry gathers data from a variety of KPNC electronic medical records (EMR) to build and follow the registry cohort across time. These data include cancer registries, pharmacy records, laboratory records, and inpatient and outpatient medical diagnoses. |
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Condition |
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Intervention | Drug: Pioglitazone
Pioglitazone tablets.
Other Name: Actos |
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
193099 | ||
Original Actual Enrollment | Same as current | ||
Actual Study Completion Date | August 2014 | ||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT01637935 | ||
Other Study ID Numbers | 01-03-TL-OPI-524 U1111-1132-3482 ( Registry Identifier: WHO ) |
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Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Takeda | ||
Study Sponsor | Takeda | ||
Collaborators |
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Investigators | Not Provided | ||
PRS Account | Takeda | ||
Verification Date | February 2018 |