Comparison · NCT04848480-sae
Insulin Icodec + Insulin Aspart vs Insulin Degludec + Insulin Aspart: 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. Insulin Icodec + Insulin Aspart vs Insulin Degludec + Insulin Aspart: serious adverse events. Trial comparisons, record NCT04848480-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04848480-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 | 0.0828 | 0.0562 | 0.12 | wilson | |
| Risk in group 2 | 0.0685 | 0.0448 | 0.103 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0143 | -0.0296 | 0.0586 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.683 | 2.14 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.662 | 2.27 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Insulin Icodec + Insulin Aspart than on Insulin Degludec + Insulin Aspart | 70.1 | 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 | Insulin Icodec + Insulin Aspart | Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly. | 24 | 290 | EG000 |
| Group 2 | Insulin Degludec + Insulin Aspart | Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly. | 20 | 292 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Week 1 to week 57
Source ClinicalTrials.gov
Trial
- Title
- A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)
- NCT number
- NCT04848480
- Phases
- PHASE3
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- insulin icodec, insulin degludec, insulin aspart
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2025-06-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04848480?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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