Randomised controlled trialcited by the Tayebat archiveabstract only checked A-INS-03 standard review
Intensive sugar control in veterans with long diabetes
Glucose control and vascular complications in veterans with type 2 diabetes.
Overview
Duckworth W et al.. N Engl J Med 2009 · PMID 19092145 · DOI 10.1056/NEJMoa0808431
Lower sugar did not reduce heart events or deaths, and side effects (mainly hypoglycaemia) were more frequent.
Does the study support the specific claim? Partly · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Effect of intensive glucose control on CV events in long-standing type 2 diabetes
- How was the study done?
Multicentre RCT
- How many people, animals or samples were studied?
1,791; Military veterans, mean age 60.4, diabetes 11.5 years, 40% prior CV event
- What was actually found?
No significant reduction in CV events or death; more adverse events.
- How large was the observed effect?
HR 0.88 (0.74-1.05) primary; HR 1.07 death
- What do the results mean in everyday life?
In long-standing diabetes, very intensive control brings little benefit and more low-sugar episodes.
- What are the study's limitations?
Smaller sample, limited power; Mostly men
- What does it say about Elawady's specific claim?
Supports C-INS-04 (no CV benefit, more hypoglycaemia).
- Do the results apply to Germany and Europe?
US veterans; transferable with caution (mostly men).
- What can explicitly not be concluded from this study?
That moderate glucose control is useless or that insulin causes death.
Scientific in-depth review
1. Full reference
- Authors
- Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD, VADT Investigators
- Journal
- N Engl J Med
- Year
- 2009
- Identifier
- PMID 19092145 DOI 10.1056/NEJMoa0808431
- Verification
- verified – PubMed E-utilities efetch, 2026-10-25
- Retracted
- no
- Corrections
PubMed lists: ErratumIn (N Engl J Med. 2009 Sep 3;361(10):1028), ErratumIn (N Engl J Med. 2009 Sep 3;361(10):1024-5. doi: 10.1056/NEJMc096250.)
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract; grants: NIDDK NIH HHS
2. Research question
Effect of intensive glucose control on CV events in long-standing type 2 diabetes
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre RCT
- Population
Military veterans, mean age 60.4, diabetes 11.5 years, 40% prior CV event
- Country
USA
- Period
not stated in abstract
- Sample size
1,791
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
Intensive control aiming for 1.5-point lower HbA1c
- Comparator
Standard control
- Endpoints
Composite of major CV events; death; microvascular
- Statistical methods
Cox regression
5. Actual results
- Results
Median HbA1c 6.9% vs 8.4%. Primary outcome 235 vs 264 (HR 0.88, 0.74-1.05; P=0.14). Death HR 1.07 (0.81-1.42). Adverse events, mainly hypoglycaemia, 24.1% vs 17.6%. Less albuminuria progression (P=0.01).
- Absolute risks
Adverse events 24.1% vs 17.6%.
- Authors' conclusion
Intensive control in poorly controlled type 2 diabetes had no significant effect on major CV events, death or microvascular complications except albuminuria progression.
6. Strengths
- RCT
- Uniform risk-factor treatment
7. Weaknesses
- Smaller sample, limited power
- Mostly men
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; limited power.
9. Assessment of the statistical interpretation
Neutral results with wide CIs; cannot exclude modest benefit or harm.
10. Relevance to the specific claim
Supports C-INS-04 (no CV benefit, more hypoglycaemia).
11. Independent contrary findings
ADVANCE (I-INS-01) and UKPDS follow-up (I-INS-02).
12. Transferability to Germany and Europe
US veterans; transferable with caution (mostly men).
13. Overall methodological judgement
Moderate-quality RCT; correctly fits the archive's caution message.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | some concerns |
| Precision of results | low |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | moderate |
| Adequacy of the interpretation (by the archive) | essentially correct but incomplete |
14. Open questions
None beyond those stated.
15. Linked fact checks
Use by the Tayebat archive
Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.
- What the archive says about the study
Listed in the archive bibliography for 'insulin-injections' without its own interpretation; used as general support for the claim that insulin intensification harms.
- A. What was actually studied?
Effect of intensive glucose control on CV events in long-standing type 2 diabetes
- B. What did the authors find?
No significant reduction in CV events or death; more adverse events.
- C. What conclusions do the authors themselves draw?
Intensive control in poorly controlled type 2 diabetes had no significant effect on major CV events, death or microvascular complications except albuminuria progression.
- D. What does the archive derive from it?
Supports that intensive control lacks benefit and increases hypoglycaemia.
- E. Is this derivation scientifically justified?
Justified for the lack of macrovascular benefit and more hypoglycaemia; the trial did not show increased mortality.
- Adequacy of the interpretation (by the archive)
- essentially correct but incomplete