Association between Pioglitazone and Bladder Cancer in a Medicare population

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15784
• EU PAS number:
  EUPAS13279
• Study ID:
  15784
• Official title and acronym:
  Association between Pioglitazone and Bladder Cancer in a Medicare population
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study utilizes a 20% random sample of Medicare Parts A, B and D claims data from 2006-2013 (2014 data may be added if it becomes available) to conduct an incident user comparative safety retrospective cohort study. The cohorts will include beneficiaries aged 66 or older with diabetes who initiate pioglitazone, a dipeptidyl-peptidase 4 inhibitors, or a sulfonylureas. Incident users of pioglitazone will be compared with incident users of a dipeptidyl-peptidase 4 inhibitors, or a sulfonylureas with respect to incidence of bladder cancer.
• Study status:
  Planned

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Gillings School of Global Public Health

Study timelines

Date when funding contract was signed

Planned: 01/04/2016

Study start date

Planned: 01/04/2016

Date of final study report

Planned: 31/10/2016

Sources of funding

Other

More details on funding

Unfunded

Study protocol

Initial protocol

PioBladderCancer_SafetyProtocol_ENCePPv25Apr2016

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable