Pioglitazone and Risk of Bladder Cancer in Patients With Type 2 Diabetes Mellitus”PROBE-PIO”Study

Condition: Bladder Cancer


  • Drug: Pioglitazone

Purpose: Pioglitazone, an agonist of the peroxisome-proliferator-activated receptor (PPAR), is a relatively new oral anti-hyperglycemic drug. Since its first approval in the USA in 1999, a potential link with bladder cancer has been a subject of debate. US Food and Drug Administration (FDA) in September, 2010 and European Medicines Agency in July, 2011 issued an alert about a potential relation between the occurrence of bladder cancer and the prescription of pioglitazone, based on the data from various studies. France banned its use in July 2011. Recently Pioglitazone was banned from India without any evidence of increased bladder cancer in our population. With this background, we plan to study the risk of bladder cancer in male type 2 diabetes subjects aged more than 50 years who are on pioglitazone therapy as compared to never-users of pioglitazone in a retrospective cohort design and provide the first data from India to the policy makers regarding the purported risk in our ethnicity and geographical area.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01935466

Sponsor: Postgraduate Institute of Medical Education and Research

Primary Outcome Measures:

  • Measure: Bladder cancer rate
  • Time Frame: Prevalent bladder cancer on pioglitazone or anti diabetic drugs for 1 year
  • Safety Issue:

Estimated Enrollment: 6107

Study Start Date: July 2013

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  • Age: minimum 50 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Male Type 2 diabetes subjects with age >50 year
  2. On anti-diabetic drugs and/or insulin for≥ 1 year
  3. Patient willing to provide informed consent to be included in the study

Exclusion Criteria:

  • 1. Bladder cancer diagnosed before the onset of Diabetes mellitus. 2. Patient not willing to participate in the study.


  • Ashu rastogi, MD, DM
  • 919781001046


  • Deptt of Endocrinology
  • Chandigarh 160012 India

View trial on ClinicalTrials.gov