Risk of Bladder Cancer in Type 2 Diabetes Patients With Pioglitazone Therapy "PROBE"
Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
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.
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research