Randomised controlled trialcited by the Tayebat archiveabstract only checked A-INS-19 standard review
Adding metformin to insulin
Combination of insulin and metformin in the treatment of type 2 diabetes.
Overview
Wulffelé MG et al.. Diabetes Care 2002 · PMID 12453950 · DOI 10.2337/diacare.25.12.2133
Metformin improved sugar control and reduced insulin need and weight gain.
Does the study support the specific claim? Yes · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Metformin added to intensive insulin in type 2 diabetes
- How was the study done?
Double-blind placebo-controlled RCT
- How many people, animals or samples were studied?
390; Insulin-treated type 2 diabetes
- What was actually found?
Better control, less insulin, less weight gain.
- How large was the observed effect?
GHb -0.7%
- What do the results mean in everyday life?
Combination lowers insulin needs.
- What are the study's limitations?
Short duration; Dropouts higher with metformin
- What does it say about Elawady's specific claim?
- Do the results apply to Germany and Europe?
Dutch data.
- What can explicitly not be concluded from this study?
That insulin can be stopped.
Scientific in-depth review
1. Full reference
- Authors
- Wulffelé MG, Kooy A, Lehert P, Bets D, Ogterop JC, Borger van der Burg B, Donker AJ, Stehouwer CD
- Journal
- Diabetes Care
- Year
- 2002
- Identifier
- PMID 12453950 DOI 10.2337/diacare.25.12.2133
- Verification
- verified – PubMed E-utilities efetch, 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract
2. Research question
Metformin added to intensive insulin in type 2 diabetes
3. Study design and population
- Study design
- Randomised controlled trial – Double-blind placebo-controlled RCT
- Population
Insulin-treated type 2 diabetes
- Country
Netherlands
- Period
16 weeks
- Sample size
390
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
Metformin + insulin
- Comparator
Placebo + insulin
- Endpoints
Glycaemic control, insulin dose, weight, lipids, hypoglycaemia
- Statistical methods
Comparison at 16 weeks
5. Actual results
- Results
Mean glucose 7.8 vs 8.8 mmol/L; GHb 6.9 vs 7.6%; insulin 63.8 vs 71.3 IU; weight -0.4 vs +1.2 kg; LDL -0.21 vs -0.02; similar hypoglycaemia.
- Absolute risks
not reported
- Authors' conclusion
Insulin plus metformin gives superior control with less insulin and weight gain.
6. Strengths
- Double-blind RCT
7. Weaknesses
- Short duration
- Dropouts higher with metformin
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
Completer analysis.
9. Assessment of the statistical interpretation
Clear effects.
10. Relevance to the specific claim
Supports C-INS-11; context for C-INS-10.
11. Independent contrary findings
12. Transferability to Germany and Europe
Dutch data.
13. Overall methodological judgement
Supports combination therapy.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | correctly reported |
14. Open questions
None beyond those stated.
15. Linked fact checks
- Insulin is the single and only cause of obesity (local or generalised) because it is the only hormone that builds fat and blocks fat breakdown (lipolysis). – Studies supporting the claim
- 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 with mixed or unclear results
- People with diabetes can stop insulin and diabetes medication by following the Tayebat system ('zero medicine'), as shown by followers who stopped insulin and are 'perfectly fine'. – Studies with mixed or unclear results
- Archive conclusion: insulin is indispensable in type 1 diabetes; in type 2 diabetes, evidence supports caution with intensive dosing, prioritising metformin, weight loss and dietary change before insulin escalation, and aiming for moderate rather than near-normal HbA1c; this is not the same as rejecting insulin. – Studies supporting the claim
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?
Metformin added to intensive insulin in type 2 diabetes
- B. What did the authors find?
Better control, less insulin, less weight gain.
- C. What conclusions do the authors themselves draw?
Insulin plus metformin gives superior control with less insulin and weight gain.
- D. What does the archive derive from it?
Supports metformin before/with insulin.
- E. Is this derivation scientifically justified?
Justified.
- Adequacy of the interpretation (by the archive)
- correctly reported