Randomised controlled trialindependent cross-checkabstract only checked★ key study I-INS-05 in-depth review
Glargine and cancer in a randomised trial
The association of basal insulin glargine and/or n-3 fatty acids with incident cancers in patients with dysglycemia.
Overview
Bordeleau L et al.. Diabetes Care 2014 · PMID 24574355 · DOI 10.2337/dc13-1468
Cancer rates were identical with glargine and standard care (1.32 per 100 person-years each).
Does the study support the specific claim? No · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Effect of glargine and n-3 fatty acids on incident cancers
- How was the study done?
Cancer substudy of the ORIGIN 2x2 factorial RCT
- How many people, animals or samples were studied?
12,537 (953 cancer events); Dysglycaemia with high CV risk, mean age 63.5
- What was actually found?
No difference in any cancer outcome.
- How large was the observed effect?
1.32 vs 1.32 per 100 PY
- What do the results mean in everyday life?
Glargine does not increase cancer within 6 years.
- What are the study's limitations?
Industry funding; 6 years may be short for some cancers
- What does it say about Elawady's specific claim?
- Do the results apply to Germany and Europe?
Multinational trial including European sites or directly applicable to EU practice.
- What can explicitly not be concluded from this study?
Effects after many decades.
Scientific in-depth review
1. Full reference
- Authors
- Bordeleau L et al.
- Journal
- Diabetes Care
- Year
- 2014
- Identifier
- PMID 24574355 DOI 10.2337/dc13-1468
- Verification
- verified – PubMed efetch 2026-10-25 (this agent)
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
ORIGIN funded by Sanofi (per main paper).
2. Research question
Effect of glargine and n-3 fatty acids on incident cancers
3. Study design and population
- Study design
- Randomised controlled trial – Cancer substudy of the ORIGIN 2x2 factorial RCT
- Population
Dysglycaemia with high CV risk, mean age 63.5
- Country
International
- Period
Median 6.2 years
- Sample size
12,537 (953 cancer events)
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
Insulin glargine
- Comparator
Standard care
- Endpoints
New or recurrent adjudicated cancer; cancer death; subtypes
- Statistical methods
Cox
5. Actual results
- Results
Cancer incidence 1.32 vs 1.32 per 100 person-years (P=0.97); no subgroup interactions; cancer mortality and specific cancers not different; HbA1c, metformin and BMI did not affect results.
- Absolute risks
not reported
- Authors' conclusion
Glargine and n-3 fatty acids have neutral associations with overall and cancer-specific outcomes.
6. Strengths
- Randomised
- Adjudicated cancers
- Long follow-up
7. Weaknesses
- Industry funding
- 6 years may be short for some cancers
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Open-label; adjudicated.
9. Assessment of the statistical interpretation
Precise null.
10. Relevance to the specific claim
Contradicts C-INS-06 and C-INS-05 (cancer).
11. Independent contrary findings
12. Transferability to Germany and Europe
Multinational trial including European sites or directly applicable to EU practice.
13. Overall methodological judgement
Strongest evidence on glargine and cancer: no effect.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | high |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
None beyond those stated.
15. Linked fact checks
- Insulin therapy in type 2 diabetes roughly doubles all-cause mortality and raises cancer, renal and cardiovascular events, with a dose-response (each extra IU/kg/day +54% mortality), compared with metformin or sulfonylureas. – Studies contradicting or limiting the claim
- Insulin glargine increases cancer risk in a dose-dependent way (and long-term use increases breast cancer). – Studies contradicting or limiting the claim