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

NCT02958956 | Completed Results

• 2 other identifiers: AD-4833_403AEUPAS10335
• Study Type: observational
• Target: 236,507
• 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.

Conditions

Diabetes Mellitus, Type 2, Cancer

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone

  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.

  15 years 5 months

• Number of 10 Most Common Cancers Associated Cases

  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.

  15 years 5 months

Secondary Outcomes (6)

• Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone

  15 years 5 months

• Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone

  15 years 5 months

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

  15 years 5 months

• Number of 10 Most Common Cancer Cases by Duration of Pioglitazone

  15 years 5 months

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

  15 years 5 months

Study Arms (2)

Ever User of Pioglitazone

Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.

Drug: Pioglitazone

Never User of Pioglitazone

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.

Interventions

Pioglitazone DRUG

Participants with diabetes who were members of the KPNC registry, and had received at least 2 prescriptions for pioglitazone within a 6-month period were followed up to 15.5 years (1997-2012) in this observational study 1.

Ever User of Pioglitazone

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.

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Related Links

• Interim Results Report
• 10 yr Study Report

MeSH Terms

Conditions

Diabetes Mellitus; Neoplasms

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: January 10, 2017

Record last verified: 2018-02