N/A
N=193,099
Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes
Diabetes · Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01637935 ↗Enrolled (actual)
193,099
Serious AEs
—
Results posted
Oct 2012
Primary outcome: Primary: Incident Diagnosis of Bladder Cancer (10-year Analysis) — 89.8; 75.9 events per 100,000 person years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pioglitazone (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incident Diagnosis of Bladder Cancer (10-year Analysis) |
89.8; 75.9 | — |
| SECONDARY Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis) |
68.2; NA; 111.6; NA; 125.8; NA | — |
| SECONDARY Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis) |
67.5; NA; 88.4; NA; 113.7; NA | — |
| SECONDARY Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis) |
69.1; NA; 96.9; NA; 101.4; NA | — |
| SECONDARY Stage of Bladder Cancer (10 Year Analysis) |
1; 1; 50; 49; 40; 38 | — |
Summary
To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01637935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.