N/A
Completed N=236,507
Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.
Diabetes Mellitus, Type 2, Cancer
Source: ClinicalTrials.gov NCT02958956 ↗
Enrolled (actual)
236,507
Serious AEs
—
Results posted
Jan 2017
Primary outcomePrimary: Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone — 1.13; 1.00; 1.00; 0.91 Ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone |
1.13; 1.00; 1.00; 0.91; 1.00; 0.88 | — |
| PRIMARY Number of 10 Most Common Cancers Associated Cases |
476; 3307; 320; 2478; 282; 2300 | — |
| SECONDARY Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone |
0.92; 1.18; 1.21; 1.36; 1.04; 1.23 | — |
| SECONDARY Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone |
55; 82; 76; 75; 119; 69 | — |
| SECONDARY Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone |
1.00; 1.30; 1.07; 1.18; 1.16; 0.84 | — |
| SECONDARY Number of 10 Most Common Cancer Cases by Duration of Pioglitazone |
118; 121; 72; 99; 66; 88 | — |
| SECONDARY Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone |
1.08; 1.24; 1.12; 1.00; 0.89; 0.95 | — |
| SECONDARY Number of 10 Most Common Cancer Cases By Dose of Pioglitazone |
129; 167; 109; 71; 92; 98 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria: 1. Age less than ( =) 4 months that started in the first 4 months after entering in the cohort.
- 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.
Data sourced from ClinicalTrials.gov (NCT02958956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.