Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes
2 other identifiers
observational
193,099
0 countries
N/A
Brief Summary
To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2004
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 7, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedResults Posted
Study results publicly available
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMarch 7, 2018
February 1, 2018
10.1 years
July 7, 2012
August 31, 2012
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incident Diagnosis of Bladder Cancer (10-year Analysis)
Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.
January 1, 1997 to December 31, 2012
Secondary Outcomes (4)
Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)
January 1, 1997 to December 31, 2012
Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)
January 1, 1997 to December 31, 2012
Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)
January 1, 1997 to December 31, 2012
Stage of Bladder Cancer (10 Year Analysis)
January 1, 1997 to December 31, 2012
Study Arms (2)
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
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- The study cohort included both patients with an established diagnosis of diabetes mellitus prior to January 1, 1997 and those who were newly diagnosed prior to December 31, 2002. Patients were eligible for the study cohort if they met any of the following criteria:
- As of January 1, 1997 they had been diagnosed with diabetes mellitus, were age 40 or older and were members of KPNC,
- They had been diagnosed with diabetes mellitus, reached age 40 between January 1, 1997 and December 31, 2002 and were KPNC members on their 40th birthday, or
- Had diabetes mellitus and were age 40 or older when they joined KPNC between January 1, 1997 and December 31, 2002.
You may not qualify if:
- Diagnosis of bladder cancer recorded in the KPNC cancer registry prior to entry to the cohort or within 6 months of entry into KPNC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- Kaiser Permanentecollaborator
- Department of Epidemiology at University of Pennsylvaniacollaborator
Related Publications (2)
Lewis JD, Ferrara A, Peng T, Hedderson M, Bilker WB, Quesenberry CP Jr, Vaughn DJ, Nessel L, Selby J, Strom BL. Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care. 2011 Apr;34(4):916-22. doi: 10.2337/dc10-1068.
PMID: 21447663RESULTLewis JD, Habel LA, Quesenberry CP, Strom BL, Peng T, Hedderson MM, Ehrlich SF, Mamtani R, Bilker W, Vaughn DJ, Nessel L, Van Den Eeden SK, Ferrara A. Pioglitazone Use and Risk of Bladder Cancer and Other Common Cancers in Persons With Diabetes. JAMA. 2015 Jul 21;314(3):265-77. doi: 10.1001/jama.2015.7996.
PMID: 26197187RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head, Pharmacoepidemiology
- Organization
- Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2012
First Posted
July 11, 2012
Study Start
July 1, 2004
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
March 7, 2018
Results First Posted
October 12, 2012
Record last verified: 2018-02