NCT02958956 is a clinical trial of Pioglitazone in Diabetes Mellitus, Type 2, Cancer, sponsored by Takeda.

Who is sponsoring NCT02958956?

NCT02958956 is sponsored by Takeda.

What drugs are being tested in NCT02958956?

Interventions in NCT02958956: Pioglitazone.

What condition does NCT02958956 study?

NCT02958956 studies Diabetes Mellitus, Type 2, Cancer.

Is NCT02958956 still recruiting?

NCT02958956 is currently completed. Last updated 7 March 2018.

Are results published for NCT02958956?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-07 · How we verify

NCT02958956

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.

Completed Results posted Last updated 7 March 2018

What this trial tests

trial testing Pioglitazone in Diabetes Mellitus, Type 2, Cancer in 236,507 participants. Completed in 29 May 2015.

Timeline

1 January 1997

Primary endpoint
29 May 2015

29 May 2015

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	236,507
Start date	1 January 1997
Primary completion	29 May 2015
Estimated completion	29 May 2015

Drugs / interventions tested

Pioglitazone (pioglitazone) — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2, Cancer — all drugs for Diabetes Mellitus, Type 2, Cancer →

Sponsor

Takeda — full company profile →

Who can join

40 and older, any sex, with Diabetes Mellitus, Type 2, Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone Primary · 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.

Prostate

Group	Value	95% CI
Full Cohort	1.13	1.02 – 1.26

Breast

Group	Value	95% CI
Full Cohort	1.00	0.88 – 1.13

Lung/Bronchus

Group	Value	95% CI
Full Cohort	1.00	0.87 – 1.15

Colon

Group	Value	95% CI
Full Cohort	0.91	0.78 – 1.05

Non-Hodgkin Lymphoma

Group	Value	95% CI
Full Cohort	1.00	0.81 – 1.23

Corpus Uteri

Group	Value	95% CI
Full Cohort	0.88	0.71 – 1.09

Pancreatic

Group	Value	95% CI
Full Cohort	1.41	1.16 – 1.71

Kidney/Renal Pelvis

Group	Value	95% CI
Full Cohort	0.95	0.76 – 1.18

Number of 10 Most Common Cancers Associated Cases Primary · 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.

Prostate

Group	Value	95% CI
Ever User of Pioglitazone	476
Never User of Pioglitazone	3307

Breast

Group	Value	95% CI
Ever User of Pioglitazone	320
Never User of Pioglitazone	2478

Lung/Bronchus

Group	Value	95% CI
Ever User of Pioglitazone	282
Never User of Pioglitazone	2300

Colon

Group	Value	95% CI
Ever User of Pioglitazone	233
Never User of Pioglitazone	1844

Non-Hodgkin Lymphoma

Group	Value	95% CI
Ever User of Pioglitazone	120
Never User of Pioglitazone	839

Corpus Uteri

Group	Value	95% CI
Ever User of Pioglitazone	118
Never User of Pioglitazone	799

Pancreatic

Group	Value	95% CI
Ever User of Pioglitazone	164
Never User of Pioglitazone	648

Kidney/Renal Pelvis

Group	Value	95% CI
Ever User of Pioglitazone	110
Never User of Pioglitazone	690

Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone Secondary · 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 tim

Prostate: <12 months ago

Group	Value	95% CI
Full Cohort	0.92	0.73 – 1.17

Prostate: 12-23 months ago

Group	Value	95% CI
Full Cohort	1.18	0.94 – 1.47

Prostate: 24-35 months ago

Group	Value	95% CI
Full Cohort	1.21	0.96 – 1.52

Prostate: 36-47 months ago

Group	Value	95% CI
Full Cohort	1.36	1.07 – 1.71

Prostate: 48-83 months ago

Group	Value	95% CI
Full Cohort	1.04	0.86 – 1.26

Prostate: 84+ months ago

Group	Value	95% CI
Full Cohort	1.23	0.95 – 1.59

Breast: <12 months ago

Group	Value	95% CI
Full Cohort	1.00	0.76 – 1.31

Breast: 12-23 months ago

Group	Value	95% CI
Full Cohort	0.84	0.62 – 1.14

Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone Secondary · 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.

Prostate: <12 months ago

Group	Value	95% CI
Ever User of Pioglitazone	55

Prostate: 12-23 months ago

Group	Value	95% CI
Ever User of Pioglitazone	82

Prostate: 24-35 months ago

Group	Value	95% CI
Ever User of Pioglitazone	76

Prostate: 36-47 months ago

Group	Value	95% CI
Ever User of Pioglitazone	75

Prostate: 48-83 months ago

Group	Value	95% CI
Ever User of Pioglitazone	119

Prostate: 84+ months ago

Group	Value	95% CI
Ever User of Pioglitazone	69

Breast: <12 months ago

Group	Value	95% CI
Ever User of Pioglitazone	42

Breast: 12-23 months ago

Group	Value	95% CI
Ever User of Pioglitazone	42

Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone Secondary · 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

Prostate: <12 months

Group	Value	95% CI
Full Cohort	1.00	0.84 – 1.19

Prostate: 12-23 months

Group	Value	95% CI
Full Cohort	1.30	1.08 – 1.57

Prostate: 24-35 months

Group	Value	95% CI
Full Cohort	1.07	0.84 – 1.35

Prostate: 36-59 months

Group	Value	95% CI
Full Cohort	1.18	0.96 – 1.45

Prostate: 60+ months

Group	Value	95% CI
Full Cohort	1.16	0.90 – 1.50

Breast: <12 months

Group	Value	95% CI
Full Cohort	0.84	0.69 – 1.03

Breast: 12-23 months

Group	Value	95% CI
Full Cohort	1.07	0.84 – 1.35

Breast: 24-35 months

Group	Value	95% CI
Full Cohort	1.01	0.75 – 1.35

Number of 10 Most Common Cancer Cases by Duration of Pioglitazone Secondary · 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.

Prostate: <12 months

Group	Value	95% CI
Ever User of Pioglitazone	118

Prostate: 12-23 months

Group	Value	95% CI
Ever User of Pioglitazone	121

Prostate: 24-35 months

Group	Value	95% CI
Ever User of Pioglitazone	72

Prostate: 36-59 months

Group	Value	95% CI
Ever User of Pioglitazone	99

Prostate: 60+ months

Group	Value	95% CI
Ever User of Pioglitazone	66

Breast: <12 months

Group	Value	95% CI
Ever User of Pioglitazone	88

Breast: 12-23 months

Group	Value	95% CI
Ever User of Pioglitazone	75

Breast: 24-35 months

Group	Value	95% CI
Ever User of Pioglitazone	47

Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone Secondary · 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

Prostate: 1-9000 mg

Group	Value	95% CI
Full Cohort	1.08	0.91 – 1.27

Prostate: 9001-25000 mg

Group	Value	95% CI
Full Cohort	1.24	1.06 – 1.46

Prostate: 25001-50000 mg

Group	Value	95% CI
Full Cohort	1.12	0.92 – 1.37

Prostate: >=50001 mg

Group	Value	95% CI
Full Cohort	1.00	0.78 – 1.28

Breast: 1-9000 mg

Group	Value	95% CI
Full Cohort	0.89	0.73 – 1.08

Breast: 9001-25000 mg

Group	Value	95% CI
Full Cohort	0.95	0.77 – 1.17

Breast: 25001-50000 mg

Group	Value	95% CI
Full Cohort	1.15	0.91 – 1.46

Breast: >=50001 mg

Group	Value	95% CI
Full Cohort	1.19	0.89 – 1.57

Number of 10 Most Common Cancer Cases By Dose of Pioglitazone Secondary · 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.

Prostate: 1-9000 mg

Group	Value	95% CI
Ever User of Pioglitazone	129

Prostate: 9001-25000 mg

Group	Value	95% CI
Ever User of Pioglitazone	167

Prostate: 25001-50000 mg

Group	Value	95% CI
Ever User of Pioglitazone	109

Prostate: >=50001 mg

Group	Value	95% CI
Ever User of Pioglitazone	71

Breast: 1-9000 mg

Group	Value	95% CI
Ever User of Pioglitazone	92

Breast: 9001-25000 mg

Group	Value	95% CI
Ever User of Pioglitazone	98

Breast: 25001-50000 mg

Group	Value	95% CI
Ever User of Pioglitazone	77

Breast: >=50001 mg

Group	Value	95% CI
Ever User of Pioglitazone	53

Sponsor's own description

The purpose of this study was to evaluate whether treatment with pioglitazone is associated with risk of incident cancer at the 10 most common sites in a cohort of participants with recognized diabetes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Pioglitazone

Trials testing the same drug.

NCT07444424 — A Study to Investigate the Effect of AZD5004 on Mitiglinide and Pioglitazone in Healthy Participants · Phase 1 · recruiting
NCT06657209 — Normal-weight Diabetes: Adipocyte-directed Therapy with Pioglitazone or Tirzepatide · Phase 4 · not yet recruiting
NCT06246799 — Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes · Phase 3 · recruiting
NCT05753657 — A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients · EARLY_PHASE1 · recruiting
NCT05305287 — Quantifying Hepatic Mitochondrial Fluxes in Humans · Phase 4 · recruiting

Other Takeda trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02958956 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 7 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02958956.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing