Epidemiologic Study Of Diabetes And Cancer Risk

NCT02958995 | Completed Results

• 2 other identifiers: AD-4833_403BEUPAS10335
• Study Type: observational
• Target: 2,738,161
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2, Cancer

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status

  Age and gender adjusted incidence rates, stratified by diabetes status, was calculated using the direct method (2000 US Census as standard), with further stratification on calendar year. Cancer incidence rates were calculated with attention to the proper allocation of at-risk person-time. The association between diabetes and risk of each of the 10 most common cancers was assessed using Cox proportional hazards regression models with control for available potential confounders: age, gender. Similarly, Cox regression technique was used to examine the association between diabetes status and cancer risk among survey responders with adjustment for additional potential confounding variable.

  15 years

• Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes

  The association between diabetes and risk of each of the 10 most common cancers was assessed by calculating hazard ratio using Cox proportional hazards regression models with control for available potential confounders: age, gender and calendar years. Cox regression techniques was used to examine the association between DM status and cancer risk with adjustment for potential confounding variables in the survey respondent cohort.

  15 years

Study Arms (2)

Full KPNC Cohort

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

Other: No Intervention

Survey Responders

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.

Other: No Intervention

Interventions

No Intervention OTHER

Full KPNC Cohort; Survey Responders

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) with pioglitazone exposure identified from the Kaiser Permanente of Northern California(KPNC) Diabetes Registry (with or without diabetes) and had completed Member Health Survey (MHS) were enrolled in the epidemiology study.

Sponsors & Collaborators

• Takeda: lead

Related Links

• Interim Results Report
• 10 Yr Study Report

MeSH Terms

Conditions

Diabetes Mellitus; Neoplasms

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 8, 2016
• Study Start: January 1, 1997
• Primary Completion: May 29, 2015
• Study Completion: May 29, 2015
• Last Updated: March 7, 2018
• Results First Posted: March 10, 2017

Record last verified: 2018-02