The association of basal insulin glargine and/or n-3 fatty acids with incident cancers in patients with dysglycemia.
Level 2 - randomized trial
Individual randomized 2x2 factorial controlled trial
PubMed 24574355 · doi:10.2337/dc13-1468
What was done
Researchers analyzed cancer outcomes within the ORIGIN trial, an international 2x2 factorial randomized controlled trial involving 12,537 participants with dysglycemia at high cardiovascular risk (mean age 63.5 years; 4,388 females). Participants were randomized to receive basal insulin glargine versus standard care, and n-3 fatty acid supplementation versus placebo (double-blind). The primary outcome for this analysis was the incidence of any new or recurrent adjudicated cancer over a median follow-up of 6.2 years, along with cancer-specific mortality and cancer subtypes.
What was found
During follow-up, 953 participants developed a cancer event. Cancer incidence was identical between the insulin glargine and standard care groups at 1.32 per 100 person-years (P = 0.97). In the n-3 fatty acid group, cancer incidence was 1.28 per 100 person-years compared to 1.36 per 100 person-years in the placebo group (P = 0.39). Subgroup analyses showed no significant interactions (all P >= 0.17). Cancer mortality and specific cancer subtypes did not differ between treatment arms, and postrandomization HbA1c, body mass index, and other glucose-lowering agents (including metformin) did not affect cancer risk.
Why it matters
Prior observational studies raised concerns that insulin glargine might increase cancer risk and suggested n-3 fatty acids could prevent cancer. This large randomized trial demonstrates that neither intervention alters overall or site-specific cancer risk over 6 years.
Limits
The median follow-up of 6.2 years may not capture malignancies with longer latency periods. The study population was restricted to older individuals with dysglycemia and high cardiovascular risk, which may limit generalizability to younger or lower-risk cohorts. Exact effect estimates with confidence intervals and specific numbers for individual cancer types were not provided in the abstract.
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