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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 Pioglitazone

Incident 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

Page last updated: August 20, 2015

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