Comparison · NCT01717313-sae
Omarigliptin vs Placebo to Omarigliptin: 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. Omarigliptin vs Placebo to Omarigliptin: serious adverse events. Trial comparisons, record NCT01717313-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01717313-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 | 0.0485 | 0.0248 | 0.0927 | wilson | |
| Risk in group 2 | 0.0488 | 0.0249 | 0.0933 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000296 | -0.0507 | 0.05 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.994 | 0.382 | 2.59 | log | |
| Odds ratio, group 1 over group 2 | 0.994 | 0.364 | 2.71 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Omarigliptin than on Placebo to Omarigliptin | 3,380 | 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 | Omarigliptin | Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B. | 8 | 165 | EG000 |
| Group 2 | Placebo to Omarigliptin | Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B. | 8 | 164 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 57 weeks for serious adverse events (SAE, including 3-week follow-up) and up to 54 weeks for non-serious adverse events.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
- NCT number
- NCT01717313
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Omarigliptin, Placebo to Omarigliptin, Metformin, Placebo to metformin, Glimepiride
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2016-07-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01717313?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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