Comparison · NCT01590771-sae
Sitagliptin vs Placebo: 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. Sitagliptin vs Placebo: serious adverse events. Trial comparisons, record NCT01590771-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01590771-sae
On this page
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 | 0.0282 | 0.0137 | 0.0571 | wilson | |
| Risk in group 2 | 0.0281 | 0.0137 | 0.0569 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000113 | -0.0321 | 0.0324 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.357 | 2.82 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.347 | 2.91 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sitagliptin than on Placebo | 8,820 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sitagliptin | Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study. | 7 | 248 | EG000 |
| Group 2 | Placebo | Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study. | 7 | 249 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 26 weeks (including 14 days following the last dose of study medication).
Source ClinicalTrials.gov
Trial
- Title
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
- NCT number
- NCT01590771
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin, Placebo, Gliclazide, Glimepiride, Metformin
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2015-05-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01590771?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01590771-sae