Comparison · NCT00386100-sae
Metformin vs Avandamet: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Metformin vs Avandamet: serious adverse events. Trial comparisons, record NCT00386100-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00386100-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0808 | 0.0561 | 0.115 | wilson | |
| Risk in group 2 | 0.0814 | 0.0569 | 0.115 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000557 | -0.0424 | 0.0415 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.993 | 0.598 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 0.993 | 0.572 | 1.72 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Metformin than on Avandamet | 1,800 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Metformin | Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg. | 27 | 334 | EG000 |
| Group 2 | Avandamet | Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg. | 28 | 344 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
An on therapy adverse event (AE)/serious adverse event (SAE) was defined as an AE/SAE with onset on or after the start date of study medication but not later than two days after the last date of study medication.
Source ClinicalTrials.gov
Trial
- Title
- A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin
- NCT number
- NCT00386100
- Phases
- PHASE4
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
Avandamet 6 mg/1500 mg (ttd), Avandamet 4 mg/1000 mg (ttd), Avandamet 2 mg/500 mg (ttd), Avandamet 8 mg/ 2000 mg (ttd), Metformin 500 mg (ttd), Metformin 1000 mg (ttd), Metformin 1500 mg (ttd), Metformin 2000 mg (ttd)
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2011-04-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00386100?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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