Insulin Glargine vs Standard Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0486 | 0.0436 | 0.0543 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.037 | 0.0326 | 0.0419 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0116 | 0.00455 | 0.0188 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.31 | 1.11 | 1.55 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.33 | 1.12 | 1.58 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Insulin Glargine than on Standard Care | 85.9 | 53.2 | 220 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: standard care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Insulin Glargine | Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids | 303 | 6,231 | EG000 | ClinicalTrials.gov |
| Group 2 | Standard Care | Standard care with or without omega-3 polyunsaturated fatty acids | 232 | 6,273 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Adverse events (AEs) were assessed through the study. The median duration of follow-up was 6.2 years. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention) | ClinicalTrials.gov |
| NCT number | NCT00069784 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Diabetes Mellitus, Non-Insulin-Dependent | ClinicalTrials.gov |
| Interventions | insulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), placebo, reusable pen device for insulin injection | ClinicalTrials.gov |
| Lead sponsor | Sanofi | ClinicalTrials.gov |
| Results first posted | 2013-01-25 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00069784?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.