Cohort Study of Pioglitazone and Bladder Cancer in Patients with Type II Diabetes

Study identification

• EU PAS number:
  EUPAS2717
• Study ID:
  15058
• Official title and acronym:
  Cohort Study of Pioglitazone and Bladder Cancer in Patients with Type II Diabetes
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Following guidance from the United States Food and Drug Administration (FDA) and European Medicine Agency, the University of Pennsylvania and Kaiser Permanente Northern California (KPNC) designed and conducted this study from 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 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. In 2012 an 8-yr interim analysis together with several sensitivity analyses and additional analyses requested by the FDA were undertaken. In 2014 the final 10-yr analysis was completed. 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Kaiser Permanente Northern California,Division of Research

Study timelines

Date when funding contract was signed

Actual:01/01/1997

Study start date

Actual:01/01/1997

Data analysis start date

Actual:01/01/1997

Date of interim report, if expected

Actual:30/03/2012

Date of final study report

Planned:01/06/2014

Actual:11/08/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Global Research & Development Center, Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)