Epidemiologic Study Of Diabetes And Cancer Risk

Takeda

Status: Completed

Conditions: Diabetes Mellitus, Type 2, Cancer

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02958995

AD-4833_403B

EUPAS10335 (Registry Identifier)

Details and patient eligibility

About

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 along with the assessment of association between diabetes severity and cancer risk.

Full description

The study enroll a large population of approximately 252467 participants. This epidemiology study of diabetes and cancer risk is an expansion study which would include estimation of cancer rate among KPNC members with or without diabetes and the relative risks of cancers associated with a diagnosis of diabetes. The study included diabetes participants who were KPNC members between 1997 and 2011. It also included a subset of participants who took the 1996/7 diabetes survey and Member Health Survey (MHS) in 1993, 1999, 2001 or 2003.

This multi-center trial was conducted in the United States of America. The overall time to participate in this study was approximately 15.5 years. The participants were followed-up from January 1, 1997 up to December 31, 2011.

Enrollment: 2,738,161 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 and had no prior diagnosis of the cancer of interest.

Trial design

2,738,161 participants in 2 patient groups

Full KPNC Cohort

Description:

Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.

Treatment:

Other: No Intervention

Survey Responders

Description:

A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.

Treatment:

Other: No Intervention