Trial · NCT02958956
Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.
NCT02958956, Completed, Takeda; results first posted 2017-01-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus. Trials, record NCT02958956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02958956
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.
- NCT number
- NCT02958956
- Status
- Completed
- Enrollment
- 236,507 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Diabetes Mellitus, Type 2, Cancer
- Interventions
- Pioglitazone
- First posted
- 2016-11-08
- Last updated
- 2018-03-07
- Results first posted
- 2017-01-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | 15 years 5 months | The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with ever use of pioglitazone. Cox proportional hazards regression modeling was used to provide point and interval estimates of the relative hazard of the 10 most common cancers associated with ever use of pioglitazone. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale. |
| Primary | Number of 10 Most Common Cancers Associated Cases | 15 years 5 months | Number of 10 most common cancer cases are reported in this measure: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma. |
| Secondary | Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone | 15 years 5 months | The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. The various times since initiation include \<12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. Cox proportional hazards regression modeling was used to provide point and interval estimates of the time since first use. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale. |
| Secondary | Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone | 15 years 5 months | Number of 10 most common cancer cases: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. Time since initiation of pioglitazone was categorized as \<12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. |
| Secondary | Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone | 15 years 5 months | The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as \<12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. Cox proportional hazards regression modeling was used to provide point and interval estimates of the cumulative duration. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale. |
| Secondary | Number of 10 Most Common Cancer Cases by Duration of Pioglitazone | 15 years 5 months | The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as \<12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. |
| Secondary | Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone | 15 years 5 months | The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 milligram (mg) and greater than or equal to (\>=) 50001 mg. Cox proportional hazards regression modeling was used to provide point and interval estimates of the dose. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale. |
| Secondary | Number of 10 Most Common Cancer Cases By Dose of Pioglitazone | 15 years 5 months | The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 mg and \>=50001 mg. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | 15 years 5 months | Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. | Ratio | NUMBER |
| PRIMARY | Number of 10 Most Common Cancers Associated Cases | 15 years 5 months | Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. | Cases | NUMBER |
| SECONDARY | Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone | 15 years 5 months | Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. | Ratio | NUMBER |
| SECONDARY | Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone | 15 years 5 months | Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure. | Cases | NUMBER |
| SECONDARY | Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone | 15 years 5 months | Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. | Ratio | NUMBER |
| SECONDARY | Number of 10 Most Common Cancer Cases by Duration of Pioglitazone | 15 years 5 months | Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure. | Cases | NUMBER |
| SECONDARY | Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone | 15 years 5 months | Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. | Ratio | NUMBER |
| SECONDARY | Number of 10 Most Common Cancer Cases By Dose of Pioglitazone | 15 years 5 months | Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.The unexposed arm was not planned to be analyzed for this outcome measure. | Cases | NUMBER |
Source ClinicalTrials.gov
Results by group330
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Prostate | 1.13 | 95% Confidence Interval 1.02 to 1.26 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Breast | 1.00 | 95% Confidence Interval 0.88 to 1.13 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Lung/Bronchus | 1.00 | 95% Confidence Interval 0.87 to 1.15 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Colon | 0.91 | 95% Confidence Interval 0.78 to 1.05 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Non-Hodgkin Lymphoma | 1.00 | 95% Confidence Interval 0.81 to 1.23 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Corpus Uteri | 0.88 | 95% Confidence Interval 0.71 to 1.09 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Pancreatic | 1.41 | 95% Confidence Interval 1.16 to 1.71 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Kidney/Renal Pelvis | 0.95 | 95% Confidence Interval 0.76 to 1.18 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Rectum | 0.81 | 95% Confidence Interval 0.60 to 1.08 | Ratio |
| Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone | Full Cohort | Melanoma | 1.15 | 95% Confidence Interval 0.91 to 1.46 | Ratio |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ever User of Pioglitazone | 38,190 | |
| Overall Study | STARTED | Never User of Pioglitazone | 198,317 | |
| Overall Study | COMPLETED | Ever User of Pioglitazone | 38,190 | |
| Overall Study | COMPLETED | Never User of Pioglitazone | 198,317 | |
| Overall Study | NOT COMPLETED | Ever User of Pioglitazone | 0 | |
| Overall Study | NOT COMPLETED | Never User of Pioglitazone | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ever User of Pioglitazone | ||
| Total, all-cause mortality | Never User of Pioglitazone | ||
| Total, other adverse events | Ever User of Pioglitazone | 0 | 0 |
| Total, other adverse events | Never User of Pioglitazone | 0 | 0 |
| Total, serious adverse events | Ever User of Pioglitazone | 0 | 0 |
| Total, serious adverse events | Never User of Pioglitazone | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02958956
GET https://conductscience.org/api/trials/v1/NCT02958956/results?page=2