Insulin glargine increases cancer risk in a dose-dependent way (and long-term use increases breast cancer).
Original statement
وفي تحليل Hemkens الألماني على 127 ألف مريض، رفع جلارجين خطر السرطان بشكل يتناسب مع الجرعة.
verbatim according to source. Translation by the project; the Arabic wording is authoritative.
Translation
Insulin glargine increases cancer risk in a dose-dependent way (and long-term use increases breast cancer).
Origin
- Source status
- Archive editors
- Attribution
- Archive editors (not Elawady)
- Origin
- https://eltayebat.com/rule/insulin-injections/
- Attribution uncertainty
- Editorial narrative and study selection written by the archive operators.
- Claimed mechanism
Mitogenic (growth-promoting) properties of glargine via IGF-1 receptor.
- Claimed health effect
Cancer, breast cancer
- Population concerned
Insulin-treated diabetes
- Geographic restriction by Elawady
none found
Scientific assessment
Mostly false – Essential parts of the statement are not supported by the evidence or are strongly exaggerated.
Certainty of evidence: moderate – Further research may still affect the assessment.
1. What was claimed?
Glargine causes cancer, dose-dependently.
2. What is demonstrably correct?
Hemkens et al. (127,031 German patients, mean follow-up 1.63 years) found, after dose adjustment, HR 1.09/1.19/1.31 for 10/30/50 IU/day of glargine vs human insulin (A-INS-04); this triggered regulatory reviews in 2009. Jonasson et al. found a higher breast-cancer RR (1.99) in women using glargine alone (A-INS-05); Suissa et al. found a possible increase after >5 years in women previously on insulin (HR 2.7, based on 10 cases) (A-INS-06). These signals are real but hypothesis-generating.
3. What is wrong or exaggerated?
In Hemkens et al. crude cancer incidence was lower with glargine (2.14 vs 2.50 per 100 person-years; unadjusted HR 0.85); the excess appeared only after modelling with a time-at-risk-based dose, was concentrated in users of >40 IU/day, and higher dose was associated with cancer for all insulin types; the authors state that causality cannot be shown (A-INS-04). Jonasson et al. found no increase for all malignancies (RR 1.07, 0.91-1.27); the breast signal (25 cases) was absent in users of glargine plus other insulins, showed no dose trend, and the authors suggest chance (A-INS-05). Suissa et al. found no overall increase (HR 1.0, 0.7-1.4) and none in the first 5 years (HR 0.9), with no dose data (A-INS-06). The randomised ORIGIN trial found no difference in cancers (HR 1.00) (A-INS-07) and, in its cancer substudy, identical incidence, cancer mortality and site-specific cancers (I-INS-05). A meta-analysis found lower odds of cancer with glargine (OR 0.81) and no breast-cancer increase (OR 0.99), with very low-quality evidence (I-INS-06).
4. What remains unclear?
Very long-term (>10 years) breast-cancer risk has limited data. The meta-analysis I-INS-06 covered mostly 1.3-4 years of follow-up and did no dose-response or duration analysis; its authors state that an increased breast-cancer risk cannot be excluded. The dose-dependent and long-term breast parts of the claim are therefore tested mainly by ORIGIN (6.2 years).
5. Which studies support it?
No study clearly supports the claim. Mixed: A-INS-04 (model-dependent dose signal), A-INS-05 (breast signal in one subgroup, overall null), A-INS-06 (long-term subgroup signal, overall null).
6. Which studies contradict it?
A-INS-07, I-INS-05, I-INS-06 (overall cancer; does not test dose or duration).
7. What applies to Germany and Europe?
The signal came from German data (AOK) and was reviewed by European regulators in 2009 (EMA statement not fetched in this audit; verified: false). Glargine remains approved in the EU.
8. What is known about Egypt?
Egypt has one of the highest diabetes prevalences in the region; the same drug classes and insulins are used. Access barriers and cost may make advice to stop medication attractive, which increases the practical risk of this claim. No Egypt-specific evidence changes the assessment.
9. What practical conclusion is appropriate?
The glargine-cancer alarm of 2009 was not confirmed by randomised evidence. People using glargine should not stop it out of fear of cancer.
Assessment details
- Rationale for certainty of evidence
The 2009 observational signal (Hemkens) was real but inconsistent (Swedish and UK data showed no overall increase); the subsequent randomised ORIGIN cancer analysis (12,537 people, 953 cancer events, 6.2 years) found identical cancer incidence (1.32 vs 1.32 per 100 person-years), and a meta-analysis of 11 studies did not support a link (very low quality). Moderate rather than high certainty because the breast-cancer question for very long use was not fully resolved.
- Source quality
Archive editorial quoting a German insurance cohort.
- Regional transferability
German, Swedish, UK data; directly relevant to Europe.
- Regional scope of the claim
- general (biological/medical)
- Last reviewed
- 25 October 2026 provisional
In plain language
In 2009 a German database study suggested that the long-acting insulin glargine might raise cancer risk. Other studies did not find the same thing, and a large randomised trial that followed over 12,000 people for six years found exactly the same cancer rate with and without glargine. The early alarm has therefore not been confirmed.
Studies on this claim
Studies supporting the claim (0)
No studies in this group.
Studies contradicting or limiting the claim (3)
-
Long-term insulin glargine in early diabetes (ORIGIN)
ORIGIN Trial Investigators; Gerstein HC et al.. N Engl J Med 2012 · PMID 22686416 · DOI 10.1056/NEJMoa1203858Randomised controlled trialcited by the Tayebat archivefull text checked★ key studyOver six years insulin did not change heart attacks, strokes or cancers, but caused more low-sugar episodes and 2 kg weight difference.
Does the study support the specific claim? No · Methodological quality: high · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Does basal insulin glargine targeting normal fasting glucose reduce CV events in dysglycaemia?
- How was the study done?
International multicentre RCT, 2x2 factorial (ORIGIN)
- How many people, animals or samples were studied?
12,537; CV risk factors plus IFG, IGT or type 2 diabetes; mean age 63.5
- What was actually found?
Neutral CV and cancer outcomes; more hypoglycaemia, slight weight gain.
- How large was the observed effect?
HR 1.02 CV; HR 1.00 cancer
- What do the results mean in everyday life?
Insulin itself did not cause heart disease or cancer in this large trial.
- What are the study's limitations?
Open-label; funded by the glargine manufacturer; early-diabetes population on moderate doses (~28 units/day for 70 kg).
- What does it say about Elawady's specific claim?
Key randomised evidence against C-INS-03, C-INS-05, C-INS-06; supports hypoglycaemia/weight side effects.
- Do the results apply to Germany and Europe?
Multinational/US/UK/European data; directly transferable to Germany/EU clinical practice.
- What can explicitly not be concluded from this study?
Safety in very high-dose, late-stage type 2 diabetes.
-
Glargine and cancer in a randomised trial
Bordeleau L et al.. Diabetes Care 2014 · PMID 24574355 · DOI 10.2337/dc13-1468Randomised controlled trialindependent cross-checkabstract only checked★ key studyCancer 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 · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
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.
-
Pooled studies of glargine and cancer
Tang X et al.. PLoS One 2012 · PMID 23284776 · DOI 10.1371/journal.pone.0051814Meta-analysisindependent cross-checkfull text checkedGlargine was not linked to more cancer, including breast cancer.
Does the study support the specific claim? No · Methodological quality: low · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Insulin glargine and cancer incidence
- How was the study done?
Meta-analysis of observational studies and RCTs with GRADE
- How many people, animals or samples were studied?
11 studies; 448,928 subjects; Diabetes patients
- What was actually found?
OR 0.81 any cancer.
- How large was the observed effect?
OR 0.81 (0.68-0.98)
- What do the results mean in everyday life?
No cancer increase.
- What are the study's limitations?
Mostly short-term observational data; very high heterogeneity; no study quality assessment; dose and long-term use not analysed; very low certainty.
- What does it say about Elawady's specific claim?
Contradicts C-INS-06.
- Do the results apply to Germany and Europe?
Includes European cohorts.
- What can explicitly not be concluded from this study?
That glargine protects against cancer, or anything about dose-dependent or long-term (>5 years) breast cancer risk.
No study in this group is marked as key.
Studies with mixed or unclear results (4)
-
Review: obesity and cancer
Calle EE et al.. Nat Rev Cancer 2004 · PMID 15286738 · DOI 10.1038/nrc1408Narrative reviewcited by the Tayebat archiveabstract only checkedNot assessed (no abstract available).
Does the study support the specific claim? Unclear · Methodological quality: low · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Epidemiology and mechanisms linking overweight/obesity and cancer
- How was the study done?
Narrative review (no abstract in PubMed; not read)
- How many people, animals or samples were studied?
not applicable; not applicable
- What was actually found?
Not assessed.
- How large was the observed effect?
not applicable
- What do the results mean in everyday life?
Not assessable.
- What are the study's limitations?
Narrative review; Not read
- What does it say about Elawady's specific claim?
Indirect background for C-INS-06.
- Do the results apply to Germany and Europe?
not applicable
- What can explicitly not be concluded from this study?
Anything about insulin injections.
-
German insurance study on glargine and cancer
Hemkens LG et al.. Diabetologia 2009 · PMID 19565214 · DOI 10.1007/s00125-009-1418-4Cohort studycited by the Tayebat archivefull text checked★ key studyWithout adjustment glargine users actually had slightly fewer cancers; only after statistical dose adjustment did glargine look somewhat worse, and follow-up was under 2 years.
Does the study support the specific claim? Partly · Methodological quality: low · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Cancer and mortality risk with human insulin vs insulin analogues
- How was the study done?
Retrospective cohort from statutory health insurance claims (AOK)
- How many people, animals or samples were studied?
127,031; Patients starting insulin monotherapy without known cancer
- What was actually found?
Dose-adjusted cancer HR up to 1.31 for glargine; no increase for other analogues.
- How large was the observed effect?
Crude incidence 2.14 (glargine) vs 2.50 (human insulin) per 100 patient-years; dose-adjusted HR 1.09-1.31.
- What do the results mean in everyday life?
An early warning signal that later trials did not confirm.
- What are the study's limitations?
Follow-up about 1.6 years; result reverses with dose adjustment; dose computed over time at risk; no data on BMI, smoking, diabetes duration; groups clinically different.
- What does it say about Elawady's specific claim?
Main support for C-INS-06.
- Do the results apply to Germany and Europe?
German data; directly relevant.
- What can explicitly not be concluded from this study?
That glargine causes cancer.
-
Swedish study of glargine and cancer
Jonasson JM et al.. Diabetologia 2009 · PMID 19588120 · DOI 10.1007/s00125-009-1444-2Cohort studycited by the Tayebat archivefull text checkedOverall cancer rates were the same; women using only glargine had more breast cancer (25 cases), which the authors say may be chance.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Short-term cancer incidence in glargine users (requested by EASD)
- How was the study done?
Nationwide register-based cohort
- How many people, animals or samples were studied?
114,841; Insulin users in Sweden
- What was actually found?
Any cancer RR 1.07 (n.s.); breast RR 1.99 in glargine-only users.
- How large was the observed effect?
All cancers RR 1.07 (0.91-1.27); breast cancer RR 1.99 in glargine-only women (5.0 vs 2.6 per 1,000 person-years).
- What do the results mean in everyday life?
No clear overall cancer risk.
- What are the study's limitations?
Only 2 years follow-up; breast signal based on 25 cases in one of many comparisons; no dose-response; many missing BMI/smoking data.
- What does it say about Elawady's specific claim?
Limits C-INS-06 (overall null).
- Do the results apply to Germany and Europe?
Swedish data; directly relevant.
- What can explicitly not be concluded from this study?
Causation.
-
Glargine and breast cancer in UK women
Suissa S et al.. Diabetologia 2011 · PMID 21614572 · DOI 10.1007/s00125-011-2190-9Cohort studycited by the Tayebat archivefull text checkedNo increase in breast cancer during the first five years; a possible increase later in a subgroup.
Does the study support the specific claim? Partly · Methodological quality: moderate · Certainty of evidence: see overall assessment of the claim
Original publication · Scientific details
Study explained simply
- What did the researchers want to find out?
Long-term glargine use and breast cancer
- How was the study done?
Matched cohort in UK GPRD
- How many people, animals or samples were studied?
15,227 (4,579 glargine); Women >=40 with type 2 diabetes on insulin
- What was actually found?
Overall HR 1.0; no increase in first 5 years; HR 2.7 after >5 years only in women already on insulin before glargine (10 cases).
- How large was the observed effect?
Overall HR 1.0 (0.7-1.4); first 5 years HR 0.9 (0.7-1.3).
- What do the results mean in everyday life?
Possible long-term question, not established.
- What are the study's limitations?
Long-term signal based on 10 cases in one subgroup; chance possible; no dose data; some baseline differences (e.g. HRT use).
- What does it say about Elawady's specific claim?
Mixed for C-INS-06.
- Do the results apply to Germany and Europe?
UK data.
- What can explicitly not be concluded from this study?
Causation.
No study in this group is marked as key.
Regional context
Germany / EU
The signal came from German data (AOK) and was reviewed by European regulators in 2009 (EMA statement not fetched in this audit; verified: false). Glargine remains approved in the EU.
Egypt
Egypt has one of the highest diabetes prevalences in the region; the same drug classes and insulins are used. Access barriers and cost may make advice to stop medication attractive, which increases the practical risk of this claim. No Egypt-specific evidence changes the assessment.
What applies in my country?
General scientific assessment
Mostly false An early observational cancer signal for glargine was not confirmed by a large randomised trial.
This statement concerns biological or medical relationships. The scientific assessment above applies regardless of the country; country-specific food data do not change it.
References
- Basal insulin and cardiovascular and other outcomes in dysglycemia.. ORIGIN Trial Investigators; Gerstein HC et al.. N Engl J Med 2012 · PMID 22686416 · DOI 10.1056/NEJMoa1203858
- The association of basal insulin glargine and/or n-3 fatty acids with incident cancers in patients with dysglycemia.. Bordeleau L et al.. Diabetes Care 2014 · PMID 24574355 · DOI 10.2337/dc13-1468
- Insulin glargine and cancer risk in patients with diabetes: a meta-analysis.. Tang X et al.. PLoS One 2012 · PMID 23284776 · DOI 10.1371/journal.pone.0051814
- Overweight, obesity and cancer: epidemiological evidence and proposed mechanisms.. Calle EE et al.. Nat Rev Cancer 2004 · PMID 15286738 · DOI 10.1038/nrc1408
- Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study.. Hemkens LG et al.. Diabetologia 2009 · PMID 19565214 · DOI 10.1007/s00125-009-1418-4
- Insulin glargine use and short-term incidence of malignancies-a population-based follow-up study in Sweden.. Jonasson JM et al.. Diabetologia 2009 · PMID 19588120 · DOI 10.1007/s00125-009-1444-2
- Long-term effects of insulin glargine on the risk of breast cancer.. Suissa S et al.. Diabetologia 2011 · PMID 21614572 · DOI 10.1007/s00125-011-2190-9