Comparison · NCT01590771-1290d417
Sitagliptin vs Placebo: Number of Participants Who Experienced an Adverse Event
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. Sitagliptin vs Placebo: Number of Participants Who Experienced an Adverse Event. Trial comparisons, record NCT01590771-1290d417. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01590771-1290d417
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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 | 0.427 | 0.367 | 0.49 | wilson | |
| Risk in group 2 | 0.394 | 0.335 | 0.455 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0338 | -0.0523 | 0.119 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.879 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 1.15 | 0.804 | 1.64 | log | |
| Number needed to treat, for one more participant with the outcome on Sitagliptin than on Placebo | 29.5 | 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. | 106 | 248 | OG000 |
| 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. | 98 | 249 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced an Adverse Event
- Description
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
- Time frame
- Up to 26 weeks
- Population
All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.
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.
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