Comparison · NCT01494987-sae
Placebo+Glimepiride vs Ranolazine+Glimepiride: 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. Placebo+Glimepiride vs Ranolazine+Glimepiride: serious adverse events. Trial comparisons, record NCT01494987-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01494987-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 | 0.0185 | 0.00722 | 0.0466 | wilson | |
| Risk in group 2 | 0.0186 | 0.00726 | 0.0469 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0000861 | -0.0305 | 0.0302 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.995 | 0.252 | 3.93 | log | |
| Odds ratio, group 1 over group 2 | 0.995 | 0.246 | 4.03 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Placebo+Glimepiride than on Ranolazine+Glimepiride | 11,600 | 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 | Placebo+Glimepiride | Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen. | 4 | 216 | EG000 |
| Group 2 | Ranolazine+Glimepiride | Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen. | 4 | 215 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 24 weeks plus 30 days
Source ClinicalTrials.gov
Trial
- Title
- Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
- NCT number
- NCT01494987
- Phases
- PHASE3
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Ranolazine, Placebo, Glimepiride, Diet, Exercise
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2014-09-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01494987?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/NCT01494987-sae