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NCT Number: NCT01637935

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

To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus.

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Key information

Conditions

Diabetes Bladder Cancer Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Following guidance from the United States Food and Drug Administration (FDA) and European Medicines Agency, the University of Pennsylvania and Kaiser Permanente Northern California (KPNC) designed and conducted this study using 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 undertaken during this period and 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 inclusion of 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.

In August 2014, the final 10-year analyses were completed and submitted to the sponsor and regulatory agencies.

Interim results previously posted on clinicaltrials.gov are available in the public archive

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

pioglitazone

Drug

Pioglitazone tablets.

Other names: Actos

Primary outcomes

  1. Incident Diagnosis of Bladder Cancer (10-year Analysis)

    Time frame: January 1, 1997 to December 31, 2012

    Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.

Secondary outcomes

  1. Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)

    Time frame: January 1, 1997 to December 31, 2012

  2. Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)

    Time frame: January 1, 1997 to December 31, 2012

  3. Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)

    Time frame: January 1, 1997 to December 31, 2012

  4. Stage of Bladder Cancer (10 Year Analysis)

    Time frame: January 1, 1997 to December 31, 2012

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Collaborators

  • Department of Epidemiology at University of Pennsylvania
  • Kaiser Permanente

Registry information

Official study title

Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2012
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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