Comparison · NCT00482729-sae
Sita/Met FDC vs Metformin: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Sita/Met FDC vs Metformin: serious adverse events. Trial comparisons, record NCT00482729-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00482729-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 | 0.0448 | 0.0312 | 0.064 | wilson | |
| Risk in group 2 | 0.0612 | 0.0449 | 0.0829 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0164 | -0.042 | 0.00878 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.732 | 0.455 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.72 | 0.436 | 1.19 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sita/Met FDC than on Metformin | 61 | 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 | Sita/Met FDC | The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. | 28 | 625 | EG000 |
| Group 2 | Metformin | The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. | 38 | 621 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Week 0 through Week 44
Source ClinicalTrials.gov
Trial
- Title
- MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
- NCT number
- NCT00482729
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- sitagliptin phosphate (+) metformin hydrochloride, metformin
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2010-03-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00482729?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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