Trial Outcomes & Findings for Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes (NCT NCT01637935)
NCT ID: NCT01637935
Last Updated: 2018-03-07
Results Overview
Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.
Recruitment status
COMPLETED
Target enrollment
193099 participants
Primary outcome timeframe
January 1, 1997 to December 31, 2012
Results posted on
2018-03-07
Participant Flow
Not applicable (database study)
Not applicable (database study)
Participant milestones
| Measure |
Pioglitazone Exposed Group
Patients ever exposed to pioglitazone.
|
Pioglitazone Unexposed Group
Patients never exposed to pioglitazone.
|
|---|---|---|
|
Overall Study
STARTED
|
34181
|
158918
|
|
Overall Study
COMPLETED
|
34181
|
158918
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes
Baseline characteristics by cohort
| Measure |
Pioglitazone Exposed Group
n=34181 Participants
Patients ever exposed to pioglitazone.
|
Pioglitazone Unexposed Group
n=158918 Participants
Patients never exposed to pioglitazone.
|
Total
n=193099 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years
|
29.2 percentage of participants
n=99 Participants
|
22.1 percentage of participants
n=107 Participants
|
51.3 percentage of participants
n=206 Participants
|
|
Age, Customized
50-59 years
|
33.0 percentage of participants
n=99 Participants
|
25.6 percentage of participants
n=107 Participants
|
58.6 percentage of participants
n=206 Participants
|
|
Age, Customized
60-69 years
|
25.7 percentage of participants
n=99 Participants
|
26.2 percentage of participants
n=107 Participants
|
51.9 percentage of participants
n=206 Participants
|
|
Age, Customized
70 years and older
|
12.0 percentage of participants
n=99 Participants
|
26.1 percentage of participants
n=107 Participants
|
38.1 percentage of participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
46.5 percentage of participants
n=99 Participants
|
46.5 percentage of participants
n=107 Participants
|
93 percentage of participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
53.5 percentage of participants
n=99 Participants
|
53.5 percentage of participants
n=107 Participants
|
107 percentage of participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
51.3 percentage of participants
n=99 Participants
|
52.3 percentage of participants
n=107 Participants
|
103.6 percentage of participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
10.2 percentage of participants
n=99 Participants
|
10.8 percentage of participants
n=107 Participants
|
21 percentage of participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14.8 percentage of participants
n=99 Participants
|
12.8 percentage of participants
n=107 Participants
|
27.6 percentage of participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13.4 percentage of participants
n=99 Participants
|
10.6 percentage of participants
n=107 Participants
|
24 percentage of participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5.9 percentage of participants
n=99 Participants
|
5.7 percentage of participants
n=107 Participants
|
11.6 percentage of participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
4.3 percentage of participants
n=99 Participants
|
7.8 percentage of participants
n=107 Participants
|
12.1 percentage of participants
n=206 Participants
|
|
Current smoker
|
20.4 percentage of participants
n=99 Participants
|
17.4 percentage of participants
n=107 Participants
|
37.8 percentage of participants
n=206 Participants
|
|
Renal function at baseline
Normal creatinine
|
77.4 percentage of participants
n=99 Participants
|
77.1 percentage of participants
n=107 Participants
|
154.5 percentage of participants
n=206 Participants
|
|
Renal function at baseline
Elevated creatinine
|
4.0 percentage of participants
n=99 Participants
|
8.7 percentage of participants
n=107 Participants
|
12.7 percentage of participants
n=206 Participants
|
|
Renal function at baseline
Missing
|
18.6 percentage of participants
n=99 Participants
|
14.1 percentage of participants
n=107 Participants
|
32.7 percentage of participants
n=206 Participants
|
|
Congestive heart failure at baseline
|
3.0 percentage of participants
n=99 Participants
|
6.9 percentage of participants
n=107 Participants
|
9.9 percentage of participants
n=206 Participants
|
|
Baseline Glycosylated Hemoglobin (HbA1c)
<7%
|
17.1 percentage of participants
n=99 Participants
|
28.6 percentage of participants
n=107 Participants
|
45.7 percentage of participants
n=206 Participants
|
|
Baseline Glycosylated Hemoglobin (HbA1c)
7-7.9%
|
18.3 percentage of participants
n=99 Participants
|
19.3 percentage of participants
n=107 Participants
|
37.6 percentage of participants
n=206 Participants
|
|
Baseline Glycosylated Hemoglobin (HbA1c)
8-8.9%
|
12.8 percentage of participants
n=99 Participants
|
10.4 percentage of participants
n=107 Participants
|
23.2 percentage of participants
n=206 Participants
|
|
Baseline Glycosylated Hemoglobin (HbA1c)
9-9.9%
|
9.7 percentage of participants
n=99 Participants
|
7.0 percentage of participants
n=107 Participants
|
16.7 percentage of participants
n=206 Participants
|
|
Baseline Glycosylated Hemoglobin (HbA1c)
≥10%
|
23.9 percentage of participants
n=99 Participants
|
17.1 percentage of participants
n=107 Participants
|
41 percentage of participants
n=206 Participants
|
|
Baseline Glycosylated Hemoglobin (HbA1c)
Missing
|
18.1 percentage of participants
n=99 Participants
|
17.5 percentage of participants
n=107 Participants
|
35.6 percentage of participants
n=206 Participants
|
|
Newly diagnosed with diabetes mellitus at the start of follow-up
|
50.8 percentage of participants
n=99 Participants
|
57.9 percentage of participants
n=107 Participants
|
108.7 percentage of participants
n=206 Participants
|
|
Diabetes duration at baseline
0-4 years
|
60.1 percentage of participants
n=99 Participants
|
62.8 percentage of participants
n=107 Participants
|
122.9 percentage of participants
n=206 Participants
|
|
Diabetes duration at baseline
5-9 years
|
9.2 percentage of participants
n=99 Participants
|
6.0 percentage of participants
n=107 Participants
|
15.2 percentage of participants
n=206 Participants
|
|
Diabetes duration at baseline
10 or more years
|
9.1 percentage of participants
n=99 Participants
|
10.9 percentage of participants
n=107 Participants
|
20 percentage of participants
n=206 Participants
|
|
Diabetes duration at baseline
Missing
|
21.6 percentage of participants
n=99 Participants
|
20.4 percentage of participants
n=107 Participants
|
42 percentage of participants
n=206 Participants
|
|
Other cancer prior to baseline
|
3.1 percentage of participants
n=99 Participants
|
5.3 percentage of participants
n=107 Participants
|
8.4 percentage of participants
n=206 Participants
|
|
Other diabetes medications
Other thiazolidinediones
|
8.2 percentage of participants
n=99 Participants
|
1.5 percentage of participants
n=107 Participants
|
9.7 percentage of participants
n=206 Participants
|
|
Other diabetes medications
Metformin
|
84.8 percentage of participants
n=99 Participants
|
45.9 percentage of participants
n=107 Participants
|
130.7 percentage of participants
n=206 Participants
|
|
Other diabetes medications
Sulfonylureas
|
89.8 percentage of participants
n=99 Participants
|
61.2 percentage of participants
n=107 Participants
|
151 percentage of participants
n=206 Participants
|
|
Other diabetes medications
Other oral hypoglycemic drugs
|
6.4 percentage of participants
n=99 Participants
|
1.4 percentage of participants
n=107 Participants
|
7.8 percentage of participants
n=206 Participants
|
|
Other diabetes medications
Insulin
|
52.7 percentage of participants
n=99 Participants
|
29.4 percentage of participants
n=107 Participants
|
82.1 percentage of participants
n=206 Participants
|
|
Other diabetes medications
Never treated with any diabetes medication
|
0.0 percentage of participants
n=99 Participants
|
14.3 percentage of participants
n=107 Participants
|
14.3 percentage of participants
n=206 Participants
|
PRIMARY outcome
Timeframe: January 1, 1997 to December 31, 2012Population: All participants.
Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.
Outcome measures
| Measure |
Pioglitazone Exposed Group
n=34181 Participants
Patients ever exposed to pioglitazone.
|
Pioglitazone Unexposed Group
n=158918 Participants
Patients never exposed to pioglitazone.
|
|---|---|---|
|
Incident Diagnosis of Bladder Cancer (10-year Analysis)
|
89.8 events per 100,000 person years
Interval 76.9 to 102.7
|
75.9 events per 100,000 person years
Interval 71.3 to 80.4
|
SECONDARY outcome
Timeframe: January 1, 1997 to December 31, 2012Outcome measures
| Measure |
Pioglitazone Exposed Group
n=34181 Participants
Patients ever exposed to pioglitazone.
|
Pioglitazone Unexposed Group
n=158918 Participants
Patients never exposed to pioglitazone.
|
|---|---|---|
|
Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)
Less than 4.5 years
|
68.2 events per 100,000 person years
Interval 54.0 to 82.5
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
|
Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)
4.5 -8.5 years
|
111.6 events per 100,000 person years
Interval 84.5 to 138.7
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
|
Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)
More than 8.0 years
|
125.8 events per 100,000 person years
Interval 82.9 to 168.7
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
SECONDARY outcome
Timeframe: January 1, 1997 to December 31, 2012Population: All participants.
Outcome measures
| Measure |
Pioglitazone Exposed Group
n=34181 Participants
Patients ever exposed to pioglitazone.
|
Pioglitazone Unexposed Group
n=158918 Participants
Patients never exposed to pioglitazone.
|
|---|---|---|
|
Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)
Less than 1.5 years
|
67.5 events per 100,000 person years
Interval 50.4 to 84.6
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
|
Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)
1.5 - 4.0 years
|
88.4 events per 100,000 person years
Interval 67.5 to 109.3
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
|
Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)
More than 4 years
|
113.7 events per 100,000 person years
Interval 84.2 to 143.2
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
SECONDARY outcome
Timeframe: January 1, 1997 to December 31, 2012Population: All participants.
Outcome measures
| Measure |
Pioglitazone Exposed Group
n=34181 Participants
Patients ever exposed to pioglitazone.
|
Pioglitazone Unexposed Group
n=158918 Participants
Patients never exposed to pioglitazone.
|
|---|---|---|
|
Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)
1 - 14000 mg
|
69.1 events per 100,000 person years
Interval 52.4 to 85.8
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
|
Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)
14001 - 40000 mg
|
96.9 events per 100,000 person years
Interval 74.0 to 119.8
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
|
Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)
>40000 mg
|
101.4 events per 100,000 person years
Interval 73.5 to 129.2
|
NA events per 100,000 person years
Not calculated for the No Pioglitazone Treatment group.
|
SECONDARY outcome
Timeframe: January 1, 1997 to December 31, 2012Population: Participants diagnosed with bladder cancer.
Outcome measures
| Measure |
Pioglitazone Exposed Group
n=186 Participants
Patients ever exposed to pioglitazone.
|
Pioglitazone Unexposed Group
n=1075 Participants
Patients never exposed to pioglitazone.
|
|---|---|---|
|
Stage of Bladder Cancer (10 Year Analysis)
PUNLMP
|
1 percentage of participants
|
1 percentage of participants
|
|
Stage of Bladder Cancer (10 Year Analysis)
In situ
|
50 percentage of participants
|
49 percentage of participants
|
|
Stage of Bladder Cancer (10 Year Analysis)
Local
|
40 percentage of participants
|
38 percentage of participants
|
|
Stage of Bladder Cancer (10 Year Analysis)
Regional
|
4 percentage of participants
|
6 percentage of participants
|
|
Stage of Bladder Cancer (10 Year Analysis)
Distant
|
2 percentage of participants
|
3 percentage of participants
|
|
Stage of Bladder Cancer (10 Year Analysis)
Undetermined
|
3 percentage of participants
|
3 percentage of participants
|
Adverse Events
Pioglitazone Exposed Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pioglitazone Unexposed Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 45 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER