Comparison · NCT00954447-sae
Linagliptin 5 mg 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
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ConductScience Library. Linagliptin 5 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00954447-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00954447-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 | 0.138 | 0.113 | 0.167 | wilson | |
| Risk in group 2 | 0.132 | 0.108 | 0.16 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00613 | -0.0317 | 0.044 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.791 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.763 | 1.46 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Linagliptin 5 mg than on Placebo | 163 | 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 | Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted. | 87 | 631 | EG001 |
| Group 2 | Placebo | Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted. | 83 | 630 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 52 weeks
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
- NCT number
- NCT00954447
- Phases
- PHASE3
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Placebo, Linagliptin
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2012-09-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00954447?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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