Clinical trial · Observational

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

Cohort Study of Pioglitazone and Cancer Incidence in Patients With Diabetes Mellitus

NCT02958956CI-TRIAL-00031973completedResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

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
Diabetes Mellitus, Type 2, Cancer	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Pioglitazone	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Ever User of Pioglitazone
description
Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
interventionNames
1. Drug: Pioglitazone
label
Never User of Pioglitazone
description
Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.

Primary outcomes (2)

measure
Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone
timeFrame
15 years 5 months
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 40 Years

Show eligibility criteria text

Inclusion Criteria:

1. has been in the KPNC diabetes registry Diabetes Mellitus (DM) registry, aged 40 years or older and are members of KPNC as of January 1, 1997, or
2. has been in the DM registry, reached aged 40 years between January 1, 1997 and June 30, 2005 and are KPNC members on their 40th birthday, or
3. has joined KPNC after January 1, 1997, aged 40 years or older when they are identified by the DM registry between January 1, 1997 and June 30, 2005.

Exclusion Criteria: 1. Age less than (\<) 40 years during study period. 2. No KPNC medication benefits at the time of entry into the cohort (baseline) or gap in medication benefit greater than equal to (\>=) 4 months that started in the first 4 months after entering in the cohort.

3\. Gap in KPNC membership \>= 4 months that started in the first 4 months after entering in the cohort.

4\. Participant with a diagnosis of Human immunodeficiency virus (HIV). 5. Participants with evidence of selected surgeries for some cancer sites. 6. All prevalent cancers at baseline, that is, all participants ever diagnosed with cancer other than non-melanoma skin cancer.

References

Publications (0)

Data not yet available

No reference posted for this study.