Diabetes Clinical Trial
Official title:
Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes
Verified date | February 2018 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus.
Status | Completed |
Enrollment | 193099 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - 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: 1. As of January 1, 1997 they had been diagnosed with diabetes mellitus, were age 40 or older and were members of KPNC, 2. 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 3. Had diabetes mellitus and were age 40 or older when they joined KPNC between January 1, 1997 and December 31, 2002. Exclusion Criteria: - Diagnosis of bladder cancer recorded in the KPNC cancer registry prior to entry to the cohort or within 6 months of entry into KPNC. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda | Department of Epidemiology at University of Pennsylvania, Kaiser Permanente |
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 Ap — View Citation
Lewis 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. 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis) | January 1, 1997 to December 31, 2012 | ||
Secondary | Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis) | January 1, 1997 to December 31, 2012 | ||
Secondary | Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis) | January 1, 1997 to December 31, 2012 | ||
Secondary | Stage of Bladder Cancer (10 Year Analysis) | January 1, 1997 to December 31, 2012 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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