Risk of Bladder Cancer in Type 2 Diabetes Patients With Pioglitazone Therapy "PROBE"

NCT01935466 | Completed

• 1 other identifier: PROBEPIO
• Study Type: observational
• Target: 6,107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

Pioglitazone; Bladder cancer; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Bladder cancer rate

  Kaplan-Meir survival curves will be generated for the two groups of pioglitazone users and non-pioglitazone users. All the data at the time point of interview will be considered censored. Bladder cancer rates among pioglitazone users and non-users will be compared by hazard ratio (HR) after Cox regression. Adjustment for various confounders like age, diabetes duration, region of residence, occupation, smoking, urinary tract disease, use of other medications like sulfonylurea, metformin, insulin, DPP-IV inhibitors and other cancers before baseline would be done.

  Prevalent bladder cancer on pioglitazone or anti diabetic drugs for 1 year

Study Arms (2)

Pioglitazone

Ever users of Pioglitazone

Drug: Pioglitazone

Other drugs

Never users of pioglitazone

Interventions

Pioglitazone DRUG

Ever users of Pioglitazone

Also known as: Pioglit,, Pioz

Pioglitazone

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study group will comprise of male type 2 diabetes subjects having used pioglitazone for one year or more. The control group will include male type 2 diabetes subjects on medications other than pioglitazone adjusted for age, household income, anti-diabetic drugs, HbA1c,smoking, renal function and other bladder disorders.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Deptt of Endocrinology

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 5, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

IN (1)