Clinical trial NCT02958956: Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.
Official title: Cohort Study of Pioglitazone and Cancer Incidence in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2, Cancer
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-11-08
Enrollment: 236507
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The study enroll a large population of approximately 252467 participants. The study would analyze association of cancer and pioglitazone in 2 cohorts based on the usage of pioglitazone. Participants in were originally planned to be followed-up from January 1, 1997 to December 31, 2005. Based on the discussion with advisory board, it was recommended to increase the study population and duration of follow-up. The follow-up period was extended to June 30, 2012 for the study.

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. Participants were followed-up from January 1, 1997 up to June 30, 2012 for the assessment of cancer risk associated with pioglitazone use.

Eligibility 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, 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.

Primary outcomes:
measure: Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone
timeFrame: 15 years 5 months
measure: Number of 10 Most Common Cancers Associated Cases
timeFrame: 15 years 5 months
Secondary outcomes:
measure: Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone
timeFrame: 15 years 5 months
measure: Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone
timeFrame: 15 years 5 months
measure: Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone
timeFrame: 15 years 5 months
measure: Number of 10 Most Common Cancer Cases by Duration of Pioglitazone
timeFrame: 15 years 5 months
measure: Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone
timeFrame: 15 years 5 months
measure: Number of 10 Most Common Cancer Cases By Dose of Pioglitazone
timeFrame: 15 years 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: