Clinical trial · Observational
Risk of Bladder Cancer in Type 2 Diabetes Patients With Pioglitazone Therapy "PROBE"
Pioglitazone and Risk of Bladder Cancer in Patients With Type 2 Diabetes Mellitus"PROBE-PIO"Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pioglitazone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pioglitazone
- description
- Ever users of Pioglitazone
- interventionNames
- Drug: Pioglitazone
- label
- Other drugs
- description
- Never users of pioglitazone
Primary outcomes (1)
- measure
- Bladder cancer rate
- timeFrame
- Prevalent bladder cancer on pioglitazone or anti diabetic drugs for 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available