Cohort studyindependent cross-checkabstract checked★ key study I-INS-127 in-depth review

Glargine, prior insulin use and breast cancer

Insulin glargine use and breast cancer risk: Associations with cumulative exposure.

Overview

Peeters PJ et al.. Acta Oncol 2016 · PMID 27150973 · DOI 10.3109/0284186X.2016.1155736

Women starting with glargine had no extra breast cancer even after 5 years; a raised risk appeared only in women with long prior use of other insulins.

Does the study support the specific claim? Partly · Methodological quality: moderate

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Relate glargine duration to breast cancer.

How was the study done?

UK cohort.

How many people, animals or samples were studied?

12,468 women.

What was actually found?

No effect in new users; HR 3.17 in long-term switchers.

How large was the observed effect?

HR 1.06 (new users >=5 y).

What do the results mean in everyday life?

Glargine itself is unlikely to be the cause.

What are the study's limitations?

Few cases.

What does it say about Elawady's specific claim?

Weakens the breast-cancer claim for glargine.

Do the results apply to Germany and Europe?

UK data.

What can explicitly not be concluded from this study?

Cannot explain the switcher signal.

Scientific in-depth review

1. Full reference

Authors
Peeters PJ et al.
Journal
Acta Oncol
Year
2016
Identifier
PMID 27150973 DOI 10.3109/0284186X.2016.1155736
Verification
verified – PubMed efetch 2026-10-26; Crossref 2026-10-26
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

Does breast cancer risk rise with duration of glargine use, accounting for prior insulin?

3. Study design and population

Study design
Cohort study – Retrospective cohort (UK CPRD) with time-dependent exposure
Population

Women with a first insulin prescription

Country

United Kingdom

Period

2002-2013

Sample size

12,468 women; 186 breast cancers

Inclusion and exclusion criteria

First-ever insulin prescription

4. Methods and endpoints

Exposure / intervention

Cumulative glargine use

Comparator

Other insulins

Endpoints

Breast cancer

Statistical methods

Cox models; p-trends

5. Actual results

Results

Insulin-naive women: no association with cumulative glargine use (p-trend 0.91), HR 1.06 (0.48-2.33) after >=5 years. Switchers with >3 years prior other insulin: HR 3.17 (1.28-7.84); non-significant trend with glargine exposure among switchers.

Absolute risks

not reported

Authors' conclusion

Glargine was not associated with increased breast cancer risk in insulin-naive patients; prior exposure to other insulins appears relevant.

6. Strengths

  • Time-dependent exposure
  • Separates new users and switchers

7. Weaknesses

  • Few cases
  • Wide CIs

8. Risk of bias

Orienting tool
ROBINS-E
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
some concerns
Rationale

Small numbers.

9. Assessment of the statistical interpretation

Imprecise; switcher signal may reflect long diabetes/insulin duration rather than glargine.

10. Relevance to the specific claim

Suggests the breast-cancer signal relates to prior long insulin exposure (switchers), not to glargine in new users.

11. Independent contrary findings

12. Transferability to Germany and Europe

Directly applicable; same biology and clinical standards in Europe.

13. Overall methodological judgement

Mixed; weakens the glargine-specific interpretation.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualitymoderate
Risk of biassome concerns
Precision of resultslow
Directnessdirect
Reproducibilitypartly replicated
Consistency with the overall evidencemixed
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

15. Linked fact checks